Clinical Trials
Clinical Studies
Adaptive Clinical Trial
Design Methodology
#Study Title
1Kidney Structural Features from Living Donors Predict Graft Failure in the Recipient.
2Phenotypic, transcriptional and functional analysis of liver mesenchymal stromal cells and their immunomodulatory properties.
3The need for novel trial designs, master protocols, and research consortia in transplantation.
4Clinical outcomes after ABO-incompatible renal transplantation.
5Managing highly sensitized renal transplant candidates in the era of kidney paired donation and the new kidney allocation system: Is there still a role for desensitization?
6Continuous glucose monitoring to assess glycemic control in the first 6 weeks after pancreas transplantation.
7Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study.
8Ten Years of Kidney Paired Donation at Mayo Clinic: The Benefits of Incorporating ABO/HLA Compatible Pairs.
9Deep Learning-Based Histopathologic Assessment of Kidney Tissue.
10Preoperative Factors Predicting Admission to the Intensive Care Unit After Kidney Transplantation.
11Daratumumab in Sensitized Kidney Transplantation: Potentials and Limitations of Experimental and Clinical Use.
12Using computer-assisted morphometrics of 5-year biopsies to identify biomarkers of late renal allograft loss.
13Safety and efficacy of eculizumab in the prevention of antibody-mediated rejection in living-donor kidney transplant recipients requiring desensitization therapy: A randomized trial.
14The Relationship Between Frailty and Decreased Physical Performance With Death on the Kidney Transplant Waiting List.
15Use of Eculizumab for Active Antibody-mediated Rejection That Occurs Early Post-kidney Transplantation: A Consecutive Series of 15 Cases.
16Modeling graft loss in patients with donor-specific antibody at baseline using the Birmingham-Mayo (BirMay) predictor: Implications for clinical trials.
17Patient experience after kidney transplant: a conceptual framework of treatment burden.
18Larger nephron size, low nephron number, and nephrosclerosis on biopsy as predictors of kidney function after donating a kidney.
19Factors at de novo donor-specific antibody initial detection associated with allograft loss: a multicenter study.
20Routine Stenting of Extravesical Ureteroneocystostomy in Kidney Transplantation: A Systematic Review and Meta-analysis.
21The importance of drug safety and tolerability in the development of new immunosuppressive therapy for transplant recipients: The Transplant Therapeutics Consortium's position statement.
22Long-term Immunosuppression Adherence After Kidney Transplant and Relationship to Allograft Histology.
23Long-term outcomes of eculizumab-treated positive crossmatch recipients: Allograft survival, histologic findings, and natural history of the donor-specific antibodies.
24Comparison of high glomerular filtration rate thresholds for identifying hyperfiltration.
25A method to reduce variability in scoring antibody-mediated rejection in renal allografts: implications for clinical trials - a retrospective study.
26Obesity and Metabolic Syndrome in Kidney Transplantation: The Role of Dietary Fructose and Systemic Endotoxemia.
27Identifying Barriers to Preemptive Kidney Transplantation in a Living Donor Transplant Cohort.
28Donor-specific hypo-responsiveness occurs in simultaneous liver-kidney transplant recipients after the first year.
29De novo donor-specific antibody following BK nephropathy: The incidence and association with antibody-mediated rejection.
30The Banff 2017 Kidney Meeting Report: Revised diagnostic criteria for chronic active T cell-mediated rejection, antibody-mediated rejection, and prospects for integrative endpoints for next-generation clinical trials.
31Comparison Between Total IgG, C1q, and C3d Single Antigen Bead Assays in Detecting Class I Complement-Binding Anti-HLA Antibodies.
32Hospital readmissions following HLA-incompatible live donor kidney transplantation: A multi-center study.
33Renal Allograft Histology at 10 Years After Transplantation in the Tacrolimus Era: Evidence of Pervasive Chronic Injury.
34The Incremental Cost of Incompatible Living Donor Kidney Transplantation: A National Cohort Analysis.
35Pancreas transplantation.
36Relationship between pre-transplant physical function and outcomes after kidney transplant.
37Impact of CXCR4/CXCL12 Blockade on Normal Plasma Cells In Vivo.
38Unique molecular changes in kidney allografts after simultaneous liver-kidney compared with solitary kidney transplantation.
39Clinical Trials for Immunosuppression in Transplantation: The Case for Reform and Change in Direction.
40Kidney Transplant With Low Levels of DSA or Low Positive B-Flow Crossmatch: An Underappreciated Option for Highly Sensitized Transplant Candidates.
41Effects of Aspirin Therapy on Ultrasound-Guided Renal Allograft Biopsy Bleeding Complications.
42The Value of Protocol Biopsies to Identify Patients With De Novo Donor-Specific Antibody at High Risk for Allograft Loss.
43Why do we have the kidney allocation system we have today? A history of the 2014 kidney allocation system.
44Survival Benefit in Older Patients Associated With Earlier Transplant With High KDPI Kidneys.
4532 Doses of Bortezomib for Desensitization Is Not Well Tolerated and Is Associated With Only Modest Reductions in Anti-HLA Antibody.
46Early subclinical inflammation correlates with outcomes in positive crossmatch kidney allografts.
47Liver Allograft Provides Immunoprotection for the Cardiac Allograft in Combined Heart-Liver Transplantation.
48Interpreting Anti-HLA Antibody Testing Data: A Practical Guide for Physicians.
49Survival Benefit with Kidney Transplants from HLA-Incompatible Live Donors.
50Predicting Individual Renal Allograft Outcomes Using Risk Models with 1-Year Surveillance Biopsy and Alloantibody Data.
51Decreased chronic cellular and antibody-mediated injury in the kidney following simultaneous liver-kidney transplantation.
52Detection and Clinical Patterns of Nephron Hypertrophy and Nephrosclerosis Among Apparently Healthy Adults.
53Underutilization of Timely Kidney Transplants in Those With Living Donors.
54Developing New Immunosuppression for the Next Generation of Transplant Recipients: The Path Forward.
55Reassessing Preemptive Kidney Transplantation in the United States: Are We Making Progress?
56Computational Biology: Modeling Chronic Renal Allograft Injury.
57Changing Kidney Allograft Histology Early Posttransplant: Prognostic Implications of 1-Year Protocol Biopsies.
58Intravitreal Antivascular Endothelial Growth Factor Therapy May Induce Proteinuria and Antibody Mediated Injury in Renal Allografts.
59Adherence to a pedometer-based physical activity intervention following kidney transplant and impact on metabolic parameters.
60Positive crossmatch kidney transplant recipients treated with eculizumab: outcomes beyond 1 year.
61Should We Be Performing More Pancreas Transplants?
62New insights regarding chronic antibody-mediated rejection and its progression to transplant glomerulopathy.
63Kidney donors at increased risk? Additional studies are needed.
64Compensatory hypertrophy of the remaining kidney in medically complex living kidney donors over the long term.
65Through a glass darkly: seeking clarity in preventing late kidney transplant failure.
66Antibody-mediated rejection despite inhibition of terminal complement.
67Differences in chronic intragraft inflammation between positive crossmatch and ABO-incompatible kidney transplantation.
68Kidney allograft function and histology in recipients dying with a functioning graft.
69Acute Antibody-Mediated Rejection in Renal Transplantation: Current Clinical Management.
70Genes and transplant outcomes: the search for "associations".
71Assessing the efficacy of kidney paired donation--performance of an integrated three-site program.
72Renal retransplantation after kidney and pancreas transplantation using the renal vessels of the failed allograft: pitfalls and pearls.
73Antibody-mediated rejection in liver transplantation: current controversies and future directions.
74Down-regulating humoral immune responses: implications for organ transplantation.
75Minimal effect of bortezomib in reducing anti-pig antibodies in human leukocyte antigen-sensitized patients: a pilot study.
76Using implantation biopsies as a surrogate to evaluate selection criteria for living kidney donors.
77Kidney allograft survival after acute rejection, the value of follow-up biopsies.
78Living donor kidney transplantation using laparoscopically procured multiple renal artery kidneys and right kidneys.
79Urine but not serum soluble urokinase receptor (suPAR) may identify cases of recurrent FSGS in kidney transplant candidates.
80Oral paricalcitol reduces the prevalence of posttransplant hyperparathyroidism: results of an open label randomized trial.
81Acute pancreas allograft rejection is associated with increased risk of graft failure in pancreas transplantation.
82Urine high and low molecular weight proteins one-year post-kidney transplant: relationship to histology and graft survival.
83Inter and intra laboratory concordance of HLA antibody results obtained by single antigen bead based assay.
84Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades.
85Five-year outcomes in living donor kidney transplants with a positive crossmatch.
86Identification and characterization of kidney transplants with good glomerular filtration rate at 1 year but subsequent progressive loss of renal function.
87The role of complement in antibody-mediated rejection in kidney transplantation.
88The impact of terminal complement blockade on the efficacy of induction with polyclonal rabbit antithymocyte globulin in living donor renal allografts.
89Long-term follow-up of patients with monoclonal gammopathy of undetermined significance after kidney transplantation.
90Renal ablation using bilateral ureteral ligation for nephrotic syndrome due to renal amyloidosis.
91Prevalence, course and impact of HLA donor-specific antibodies in liver transplantation in the first year.
92Intragraft gene expression in positive crossmatch kidney allografts: ongoing inflammation mediates chronic antibody-mediated injury.
93The pathology and clinical features of early recurrent membranous glomerulonephritis.
94Kidney allograft inflammation and fibrosis, causes and consequences.
95Relationship between FKBP5 polymorphisms and depression symptoms among kidney transplant recipients.
96Terminal complement inhibition decreases antibody-mediated rejection in sensitized renal transplant recipients.
97Bilateral native ureteral ligation without nephrectomy in the management of kidney transplant recipients with native proteinuria.
98Free fatty acid storage in human visceral and subcutaneous adipose tissue: role of adipocyte proteins.
99New therapeutic approaches to antibody-mediated rejection in renal transplantation.
100Combined heart and kidney transplantation provides an excellent survival and decreases risk of cardiac cellular rejection and coronary allograft vasculopathy.
101Improving long-term renal allograft survival via a road less traveled by.
102Long-term outcomes of patients with light chain amyloidosis (AL) after renal transplantation with or without stem cell transplantation.
103Association of kidney function and metabolic risk factors with density of glomeruli on renal biopsy samples from living donors.
104The impact of proteasome inhibition on alloantibody-producing plasma cells in vivo.
105Abnormal circadian blood pressure pattern 1-year after kidney transplantation is associated with subsequent lower glomerular filtration rate in recipients without rejection.
106The histology of solitary renal allografts at 1 and 5 years after transplantation.
107The effect of coronary angiography on renal function in preemptive renal transplant candidates.
108Fibrosis with inflammation at one year predicts transplant functional decline.
109The (re)emergence of B cells in organ transplantation.
110The right kidney for the right recipient: the status of deceased donor kidney allocation reform.
111The association between age and nephrosclerosis on renal biopsy among healthy adults.
112Sensitized renal transplant recipients: current protocols and future directions.
113Significance and implications of capillaritis during acute rejection of kidney allografts.
114Epidemiology of infections requiring hospitalization during long-term follow-up of pancreas transplantation.
115Baseline donor-specific antibody levels and outcomes in positive crossmatch kidney transplantation.
116Prevalence of renal artery and kidney abnormalities by computed tomography among healthy adults.
117The outcome of patients with nephrogenic systemic fibrosis after successful kidney transplantation.
118Clinical management of renal transplant patients with donor-specific alloantibody: the state of the art.
119Deciphering antibody-mediated rejection: new insights into mechanisms and treatment.
120Antibody-mediated rejection following transplantation from an HLA-identical sibling.
121Developing a new kidney allocation policy: the rationale for including life years from transplant.
122Posttransplant lymphoproliferative disorder following pancreas transplantation.
123Patient survival after kidney transplantation: relationship to pretransplant cardiac troponin T levels.
124Mechanisms of alloantibody production in sensitized renal allograft recipients.
125Kidney transplantation for primary focal segmental glomerulosclerosis: outcomes and response to therapy for recurrence.
126Identifying specific causes of kidney allograft loss.
127Pulmonary hypertension is associated with reduced patient survival after kidney transplantation.
128Alloantibody levels and acute humoral rejection early after positive crossmatch kidney transplantation.
129Proteasome inhibition causes apoptosis of normal human plasma cells preventing alloantibody production.
130Transplant glomerulopathy: risk and prognosis related to anti-human leukocyte antigen class II antibody levels.
131Survival of patients on the kidney transplant wait list: relationship to cardiac troponin T.
132Long-term benefits of pancreas transplantation.
133The spectrum of antibody-mediated renal allograft injury: implications for treatment.
134Kidney transplant histology after one year of continuous therapy with sirolimus compared with tacrolimus.
135Patient survival and cardiovascular risk after kidney transplantation: the challenge of diabetes.
136Transplant glomerulopathy.
137Two novel assays of alloantibody-secreting cells demonstrating resistance to desensitization with IVIG and rATG.
138ABO incompatible kidney transplantation.
139Posttransplant diabetes mellitus after pancreas transplantation.
140Proteinuria after kidney transplantation, relationship to allograft histology and survival.
141What can be learned using microarrays?
142The effect of antithymocyte globulin on anti-human leukocyte antigen antibody detection assays.
143Transplant glomerulopathy: subclinical incidence and association with alloantibody.
144Molecular evidence of injury and inflammation in normal and fibrotic renal allografts one year posttransplant.
145The rationale for the new deceased donor pancreas allocation schema.
146Recurrence of ANCA-associated vasculitis following renal transplantation in the modern era of immunosupression.
147Polyomavirus-associated nephropathy risk in kidney transplants: the influence of recipient age and donor gender.
148Diurnal blood pressure changes one year after kidney transplantation: relationship to allograft function, histology, and resistive index.
149A meta-analysis of kidney microarray datasets: investigation of cytokine gene detection and correlation with rt-PCR and detection thresholds.
150Assessment of changes in kidney allograft function using creatinine-based estimates of glomerular filtration rate.
151Comparison of low versus high tacrolimus levels in kidney transplantation: assessment of efficacy by protocol biopsies.
152Kidney transplantation in patients with antibodies against donor HLA class II.
153Preemptive living donor kidney transplantation: do the benefits extend to all recipients?
154The effect of desensitization protocols on human splenic B-cell populations in vivo.
155Glomerular volume and renal histology in obese and non-obese living kidney donors.
156Complications, resource utilization, and cost of ABO-incompatible living donor kidney transplantation.
157Interpreting post-transplant proteinuria in patients with proteinuria pre-transplant.
158Histologic findings one year after positive crossmatch or ABO blood group incompatible living donor kidney transplantation.
159Collapsing and non-collapsing focal segmental glomerulosclerosis in kidney transplants.
160Kidney transplant function and histological clearance of virus following diagnosis of polyomavirus-associated nephropathy (PVAN).
161Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus.
162A comparison of plasmapheresis versus high-dose IVIG desensitization in renal allograft recipients with high levels of donor specific alloantibody.
163A Comparison of splenectomy versus intensive posttransplant antidonor blood group antibody monitoring without splenectomy in ABO-incompatible kidney transplantation.
164Improving the prediction of donor kidney quality: deceased donor score and resistive indices.
165Prognostic analysis for survival in adult solid organ transplant recipients with post-transplantation lymphoproliferative disorders.
166Predicting subsequent decline in kidney allograft function from early surveillance biopsies.
167Outcome of untreated grade II rejection on solitary pancreas allograft biopsy specimens.
168Early subclinical coronary artery calcification in young adults who were pediatric kidney transplant recipients.
169Living donor kidney and autologous stem cell transplantation for primary systemic amyloidosis (AL) with predominant renal involvement.
170New onset hyperglycemia and diabetes are associated with increased cardiovascular risk after kidney transplantation.
171United Network for Organ Sharing's expanded criteria donors: is stratification useful?
172Kidney allograft fibrosis and atrophy early after living donor transplantation.
173Obesity in living kidney donors: clinical characteristics and outcomes in the era of laparoscopic donor nephrectomy.
174Conquering absolute contraindications to transplantation: positive-crossmatch and ABO-incompatible kidney transplantation.
175Differences between early and late posttransplant lymphoproliferative disorders in solid organ transplant patients: are they two different diseases?
176A novel model of allograft rejection: immune reconstitution of Rag-1 recipients with 2C transgenic T-cell receptor lymphocytes.
177Immunomodulation through inhibition of multiple adhesion molecules generates resistance to autoimmune diabetes in NOD mice.
178Patient and graft outcomes from older living kidney donors are similar to those from younger donors despite lower GFR.
179ABO-incompatible kidney transplantation.
180Hand-assisted laparoscopic donor nephrectomy for pediatric kidney allograft recipients.
181Acute nephrotoxicity of tacrolimus and sirolimus in renal isografts: differential intragraft expression of transforming growth factor-beta1 and alpha-smooth muscle actin.
182Blood pressure and renal function after kidney donation from hypertensive living donors.
183Persistence of low levels of alloantibody after desensitization in crossmatch-positive living-donor kidney transplantation.
184Plasma exchange conditioning for ABO-incompatible renal transplantation.
185Wound-healing complications after kidney transplantation: a prospective, randomized comparison of sirolimus and tacrolimus.
186Pancreas transplants: experience with 232 percutaneous US-guided biopsy procedures in 88 patients.
187Decline in native renal function early after bladder-drained pancreas transplantation alone.
188Pancreas-after-kidney transplantation: an increasingly attractive alternative to simultaneous pancreas-kidney transplantation.
189Tolerance for immunosuppression in organ transplantation.
190Correlation of quantitative digital image analysis with the glomerular filtration rate in chronic allograft nephropathy.
191Measured and estimated GFR in healthy potential kidney donors.
192Histologic findings of antibody-mediated rejection in ABO blood-group-incompatible living-donor kidney transplantation.
193Living-donor kidney transplantation at Mayo Clinic--Rochester.
194Blood pressure evaluation among older living kidney donors.
195Overcoming a positive crossmatch in living-donor kidney transplantation.
196Accommodation in ABO-incompatible kidney allografts, a novel mechanism of self-protection against antibody-mediated injury.
197Influence of surveillance renal allograft biopsy on diagnosis and prognosis of polyomavirus-associated nephropathy.
198Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: results at three years.
199Improved scoring system to assess adult donors for cadaver renal transplantation.
200Kidney transplantation without calcineurin inhibitors using sirolimus.

Innovative Clinical Trials

Adaptive trial design (ATD) is a methodology in which a clinical trial evolves or adapts as the trial proceeds depending on the outcomes of patients enrolled. The criteria for these decisions are set prior to the beginning of the studies. An adaptive design makes use of standard statistical methods (i.e. frequentist) to halt the trial early for toxicity (dangerous substance), futility (no improvement over a control), or efficacy (great improvement over a control).

ATD has been shown to be an attractive alternative to conventional study designs for several reasons. The most important reason is that it can “learn” from relatively small numbers of study subjects. In our calculations, as few as 8 patients can be used to decide if a therapy is ineffective. Another aspect of ATD that enhances efficiency is that it uses a single ongoing control group rather than having a different control group for each experimental group. Thus, the vast majority of patients can be assigned to an experimental group. This maximizes the number of different studies that can be performed in a small population of patients. ATD also minimizes the number of patients receiving ineffective treatments and thus limits unnecessary treatment risks in study patients. This is an important reason why the FDA has enthusiastically supported adaptive trial design studies.

ATD studies commonly employ a surrogate endpoint to decide efficacy. For example, in cancer studies, a decrease in tumor size is an accepted surrogate endpoint for drug approval. In our studies, we will use the biopsy findings of antibody mediated rejection as a surrogate endpoint. In most cases, however, ATD are used in Phase II clinical trials as a way of efficiently predicting the probability that a given therapy will be successful in a subsequent definitive Phase III trial. If a surrogate endpoint is used, the drug might receive interim approval (ex. under Subpart H or other mechanisms) allowing it to be marketed and sold, but also requiring follow-up on treated patients to show the drug actually improves a clinical endpoint such as patient survival (or graft survival in the case of renal transplantation).

ATD is supported by pharmaceutical companies because it has the possibility of significantly decreasing the time and money needed to show efficacy of a drug. Indeed, it is common for otherwise competing drug companies to support an ATD study jointly in an effort to save money and time using this mechanism.

ATD has not been used in transplantation. We believe that ATD is extremely well-suited for all types of transplantation studies and initially intend to use them in studies in the treatment of late graft loss due to antibody mediated rejection.