Research

Clinical Trials
Clinical Studies
Adaptive Clinical Trial
Design Methodology
#Study Title
1Continuous glucose monitoring to assess glycemic control in the first 6 weeks after pancreas transplantation.
2Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study.
3Ten Years of Kidney Paired Donation at Mayo Clinic: The Benefits of Incorporating ABO/HLA Compatible Pairs.
4Deep Learning-Based Histopathologic Assessment of Kidney Tissue.
5Preoperative Factors Predicting Admission to the Intensive Care Unit After Kidney Transplantation.
6Daratumumab in Sensitized Kidney Transplantation: Potentials and Limitations of Experimental and Clinical Use.
7Using computer-assisted morphometrics of 5-year biopsies to identify biomarkers of late renal allograft loss.
8Safety and efficacy of eculizumab in the prevention of antibody-mediated rejection in living-donor kidney transplant recipients requiring desensitization therapy: A randomized trial.
9The Relationship Between Frailty and Decreased Physical Performance With Death on the Kidney Transplant Waiting List.
10Use of Eculizumab for Active Antibody-Mediated Rejection that Occurs Early Post-Kidney Transplantation: A Consecutive Series of 15 Cases.
11Modeling graft loss in patients with donor-specific antibody at baseline using the Birmingham-Mayo (BirMay) predictor: Implications for clinical trials.
12Patient experience after kidney transplant: a conceptual framework of treatment burden.
13Larger nephron size, low nephron number, and nephrosclerosis on biopsy as predictors of kidney function after donating a kidney.
14Factors at de novo donor-specific antibody initial detection associated with allograft loss: a multicenter study.
15Routine Stenting of Extravesical Ureteroneocystostomy in Kidney Transplantation: A Systematic Review and Meta-analysis.
16The importance of drug safety and tolerability in the development of new immunosuppressive therapy for transplant recipients: The Transplant Therapeutics Consortium's position statement.
17Long-term Immunosuppression Adherence After Kidney Transplant and Relationship to Allograft Histology.
18Long-term outcomes of eculizumab-treated positive crossmatch recipients: Allograft survival, histologic findings, and natural history of the donor-specific antibodies.
19Comparison of high glomerular filtration rate thresholds for identifying hyperfiltration.
20A method to reduce variability in scoring antibody-mediated rejection in renal allografts: implications for clinical trials - a retrospective study.
21Obesity and Metabolic Syndrome in Kidney Transplantation: The Role of Dietary Fructose and Systemic Endotoxemia.
22Identifying Barriers to Preemptive Kidney Transplantation in a Living Donor Transplant Cohort.
23Donor-specific hypo-responsiveness occurs in simultaneous liver-kidney transplant recipients after the first year.
24De novo donor-specific antibody following BK nephropathy: The incidence and association with antibody-mediated rejection.
25The 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.
26Comparison Between Total IgG, C1q, and C3d Single Antigen Bead Assays in Detecting Class I Complement-Binding Anti-HLA Antibodies.
27Hospital readmissions following HLA-incompatible live donor kidney transplantation: A multi-center study.
28Renal Allograft Histology at 10 Years After Transplantation in the Tacrolimus Era: Evidence of Pervasive Chronic Injury.
29The Incremental Cost of Incompatible Living Donor Kidney Transplantation: A National Cohort Analysis.
30Pancreas transplantation.
31Relationship between pre-transplant physical function and outcomes after kidney transplant.
32Impact of CXCR4/CXCL12 Blockade on Normal Plasma Cells In Vivo.
33Unique molecular changes in kidney allografts after simultaneous liver-kidney compared with solitary kidney transplantation.
34Clinical Trials for Immunosuppression in Transplantation: The Case for Reform and Change in Direction.
35Kidney Transplant With Low Levels of DSA or Low Positive B-Flow Crossmatch: An Underappreciated Option for Highly Sensitized Transplant Candidates.
36Effects of Aspirin Therapy on Ultrasound-Guided Renal Allograft Biopsy Bleeding Complications.
37The Value of Protocol Biopsies to Identify Patients With De Novo Donor-Specific Antibody at High Risk for Allograft Loss.
38Why do we have the kidney allocation system we have today? A history of the 2014 kidney allocation system.
39Survival Benefit in Older Patients Associated With Earlier Transplant With High KDPI Kidneys.
4032 Doses of Bortezomib for Desensitization Is Not Well Tolerated and Is Associated With Only Modest Reductions in Anti-HLA Antibody.
41Early subclinical inflammation correlates with outcomes in positive crossmatch kidney allografts.
42Liver Allograft Provides Immunoprotection for the Cardiac Allograft in Combined Heart-Liver Transplantation.
43Interpreting Anti-HLA Antibody Testing Data: A Practical Guide for Physicians.
44Survival Benefit with Kidney Transplants from HLA-Incompatible Live Donors.
45Predicting Individual Renal Allograft Outcomes Using Risk Models with 1-Year Surveillance Biopsy and Alloantibody Data.
46Decreased chronic cellular and antibody-mediated injury in the kidney following simultaneous liver-kidney transplantation.
47Detection and Clinical Patterns of Nephron Hypertrophy and Nephrosclerosis Among Apparently Healthy Adults.
48Underutilization of Timely Kidney Transplants in Those With Living Donors.
49Developing New Immunosuppression for the Next Generation of Transplant Recipients: The Path Forward.
50Reassessing Preemptive Kidney Transplantation in the United States: Are We Making Progress?
51Computational Biology: Modeling Chronic Renal Allograft Injury.
52Changing Kidney Allograft Histology Early Posttransplant: Prognostic Implications of 1-Year Protocol Biopsies.
53Intravitreal Antivascular Endothelial Growth Factor Therapy May Induce Proteinuria and Antibody Mediated Injury in Renal Allografts.
54Adherence to a pedometer-based physical activity intervention following kidney transplant and impact on metabolic parameters.
55Positive crossmatch kidney transplant recipients treated with eculizumab: outcomes beyond 1 year.
56Should We Be Performing More Pancreas Transplants?
57New insights regarding chronic antibody-mediated rejection and its progression to transplant glomerulopathy.
58Kidney donors at increased risk? Additional studies are needed.
59Compensatory hypertrophy of the remaining kidney in medically complex living kidney donors over the long term.
60Through a glass darkly: seeking clarity in preventing late kidney transplant failure.
61Antibody-mediated rejection despite inhibition of terminal complement.
62Differences in chronic intragraft inflammation between positive crossmatch and ABO-incompatible kidney transplantation.
63Kidney allograft function and histology in recipients dying with a functioning graft.
64Acute Antibody-Mediated Rejection in Renal Transplantation: Current Clinical Management.
65Genes and transplant outcomes: the search for "associations".
66Assessing the efficacy of kidney paired donation--performance of an integrated three-site program.
67Renal retransplantation after kidney and pancreas transplantation using the renal vessels of the failed allograft: pitfalls and pearls.
68Antibody-mediated rejection in liver transplantation: current controversies and future directions.
69Down-regulating humoral immune responses: implications for organ transplantation.
70Minimal effect of bortezomib in reducing anti-pig antibodies in human leukocyte antigen-sensitized patients: a pilot study.
71Using implantation biopsies as a surrogate to evaluate selection criteria for living kidney donors.
72Kidney allograft survival after acute rejection, the value of follow-up biopsies.
73Living donor kidney transplantation using laparoscopically procured multiple renal artery kidneys and right kidneys.
74Urine but not serum soluble urokinase receptor (suPAR) may identify cases of recurrent FSGS in kidney transplant candidates.
75Oral paricalcitol reduces the prevalence of posttransplant hyperparathyroidism: results of an open label randomized trial.
76Acute pancreas allograft rejection is associated with increased risk of graft failure in pancreas transplantation.
77Urine high and low molecular weight proteins one-year post-kidney transplant: relationship to histology and graft survival.
78Inter and intra laboratory concordance of HLA antibody results obtained by single antigen bead based assay.
79Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades.
80Five-year outcomes in living donor kidney transplants with a positive crossmatch.
81Identification and characterization of kidney transplants with good glomerular filtration rate at 1 year but subsequent progressive loss of renal function.
82The role of complement in antibody-mediated rejection in kidney transplantation.
83The impact of terminal complement blockade on the efficacy of induction with polyclonal rabbit antithymocyte globulin in living donor renal allografts.
84Long-term follow-up of patients with monoclonal gammopathy of undetermined significance after kidney transplantation.
85Renal ablation using bilateral ureteral ligation for nephrotic syndrome due to renal amyloidosis.
86Prevalence, course and impact of HLA donor-specific antibodies in liver transplantation in the first year.
87Intragraft gene expression in positive crossmatch kidney allografts: ongoing inflammation mediates chronic antibody-mediated injury.
88The pathology and clinical features of early recurrent membranous glomerulonephritis.
89Kidney allograft inflammation and fibrosis, causes and consequences.
90Relationship between FKBP5 polymorphisms and depression symptoms among kidney transplant recipients.
91Terminal complement inhibition decreases antibody-mediated rejection in sensitized renal transplant recipients.
92Bilateral native ureteral ligation without nephrectomy in the management of kidney transplant recipients with native proteinuria.
93Free fatty acid storage in human visceral and subcutaneous adipose tissue: role of adipocyte proteins.
94New therapeutic approaches to antibody-mediated rejection in renal transplantation.
95Combined heart and kidney transplantation provides an excellent survival and decreases risk of cardiac cellular rejection and coronary allograft vasculopathy.
96Improving long-term renal allograft survival via a road less traveled by.
97Long-term outcomes of patients with light chain amyloidosis (AL) after renal transplantation with or without stem cell transplantation.
98Association of kidney function and metabolic risk factors with density of glomeruli on renal biopsy samples from living donors.
99The impact of proteasome inhibition on alloantibody-producing plasma cells in vivo.
100Abnormal circadian blood pressure pattern 1-year after kidney transplantation is associated with subsequent lower glomerular filtration rate in recipients without rejection.
101The histology of solitary renal allografts at 1 and 5 years after transplantation.
102The effect of coronary angiography on renal function in preemptive renal transplant candidates.
103Fibrosis with inflammation at one year predicts transplant functional decline.
104The (re)emergence of B cells in organ transplantation.
105The right kidney for the right recipient: the status of deceased donor kidney allocation reform.
106The association between age and nephrosclerosis on renal biopsy among healthy adults.
107Sensitized renal transplant recipients: current protocols and future directions.
108Significance and implications of capillaritis during acute rejection of kidney allografts.
109Epidemiology of infections requiring hospitalization during long-term follow-up of pancreas transplantation.
110Baseline donor-specific antibody levels and outcomes in positive crossmatch kidney transplantation.
111Prevalence of renal artery and kidney abnormalities by computed tomography among healthy adults.
112The outcome of patients with nephrogenic systemic fibrosis after successful kidney transplantation.
113Clinical management of renal transplant patients with donor-specific alloantibody: the state of the art.
114Deciphering antibody-mediated rejection: new insights into mechanisms and treatment.
115Antibody-mediated rejection following transplantation from an HLA-identical sibling.
116Developing a new kidney allocation policy: the rationale for including life years from transplant.
117Posttransplant lymphoproliferative disorder following pancreas transplantation.
118Patient survival after kidney transplantation: relationship to pretransplant cardiac troponin T levels.
119Mechanisms of alloantibody production in sensitized renal allograft recipients.
120Kidney transplantation for primary focal segmental glomerulosclerosis: outcomes and response to therapy for recurrence.
121Identifying specific causes of kidney allograft loss.
122Pulmonary hypertension is associated with reduced patient survival after kidney transplantation.
123Alloantibody levels and acute humoral rejection early after positive crossmatch kidney transplantation.
124Proteasome inhibition causes apoptosis of normal human plasma cells preventing alloantibody production.
125Transplant glomerulopathy: risk and prognosis related to anti-human leukocyte antigen class II antibody levels.
126Survival of patients on the kidney transplant wait list: relationship to cardiac troponin T.
127Long-term benefits of pancreas transplantation.
128The spectrum of antibody-mediated renal allograft injury: implications for treatment.
129Kidney transplant histology after one year of continuous therapy with sirolimus compared with tacrolimus.
130Patient survival and cardiovascular risk after kidney transplantation: the challenge of diabetes.
131Transplant glomerulopathy.
132Two novel assays of alloantibody-secreting cells demonstrating resistance to desensitization with IVIG and rATG.
133ABO incompatible kidney transplantation.
134Posttransplant diabetes mellitus after pancreas transplantation.
135Proteinuria after kidney transplantation, relationship to allograft histology and survival.
136What can be learned using microarrays?
137The effect of antithymocyte globulin on anti-human leukocyte antigen antibody detection assays.
138Transplant glomerulopathy: subclinical incidence and association with alloantibody.
139Molecular evidence of injury and inflammation in normal and fibrotic renal allografts one year posttransplant.
140The rationale for the new deceased donor pancreas allocation schema.
141Recurrence of ANCA-associated vasculitis following renal transplantation in the modern era of immunosupression.
142Polyomavirus-associated nephropathy risk in kidney transplants: the influence of recipient age and donor gender.
143Diurnal blood pressure changes one year after kidney transplantation: relationship to allograft function, histology, and resistive index.
144A meta-analysis of kidney microarray datasets: investigation of cytokine gene detection and correlation with rt-PCR and detection thresholds.
145Assessment of changes in kidney allograft function using creatinine-based estimates of glomerular filtration rate.
146Comparison of low versus high tacrolimus levels in kidney transplantation: assessment of efficacy by protocol biopsies.
147Kidney transplantation in patients with antibodies against donor HLA class II.
148Preemptive living donor kidney transplantation: do the benefits extend to all recipients?
149The effect of desensitization protocols on human splenic B-cell populations in vivo.
150Glomerular volume and renal histology in obese and non-obese living kidney donors.
151Complications, resource utilization, and cost of ABO-incompatible living donor kidney transplantation.
152Interpreting post-transplant proteinuria in patients with proteinuria pre-transplant.
153Histologic findings one year after positive crossmatch or ABO blood group incompatible living donor kidney transplantation.
154Collapsing and non-collapsing focal segmental glomerulosclerosis in kidney transplants.
155Kidney transplant function and histological clearance of virus following diagnosis of polyomavirus-associated nephropathy (PVAN).
156Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus.
157A comparison of plasmapheresis versus high-dose IVIG desensitization in renal allograft recipients with high levels of donor specific alloantibody.
158A Comparison of splenectomy versus intensive posttransplant antidonor blood group antibody monitoring without splenectomy in ABO-incompatible kidney transplantation.
159Improving the prediction of donor kidney quality: deceased donor score and resistive indices.
160Prognostic analysis for survival in adult solid organ transplant recipients with post-transplantation lymphoproliferative disorders.
161Predicting subsequent decline in kidney allograft function from early surveillance biopsies.
162Outcome of untreated grade II rejection on solitary pancreas allograft biopsy specimens.
163Early subclinical coronary artery calcification in young adults who were pediatric kidney transplant recipients.
164Living donor kidney and autologous stem cell transplantation for primary systemic amyloidosis (AL) with predominant renal involvement.
165New onset hyperglycemia and diabetes are associated with increased cardiovascular risk after kidney transplantation.
166United Network for Organ Sharing's expanded criteria donors: is stratification useful?
167Kidney allograft fibrosis and atrophy early after living donor transplantation.
168Obesity in living kidney donors: clinical characteristics and outcomes in the era of laparoscopic donor nephrectomy.
169Conquering absolute contraindications to transplantation: positive-crossmatch and ABO-incompatible kidney transplantation.
170Differences between early and late posttransplant lymphoproliferative disorders in solid organ transplant patients: are they two different diseases?
171A novel model of allograft rejection: immune reconstitution of Rag-1 recipients with 2C transgenic T-cell receptor lymphocytes.
172Immunomodulation through inhibition of multiple adhesion molecules generates resistance to autoimmune diabetes in NOD mice.
173Patient and graft outcomes from older living kidney donors are similar to those from younger donors despite lower GFR.
174ABO-incompatible kidney transplantation.
175Hand-assisted laparoscopic donor nephrectomy for pediatric kidney allograft recipients.
176Acute nephrotoxicity of tacrolimus and sirolimus in renal isografts: differential intragraft expression of transforming growth factor-beta1 and alpha-smooth muscle actin.
177Blood pressure and renal function after kidney donation from hypertensive living donors.
178Persistence of low levels of alloantibody after desensitization in crossmatch-positive living-donor kidney transplantation.
179Plasma exchange conditioning for ABO-incompatible renal transplantation.
180Wound-healing complications after kidney transplantation: a prospective, randomized comparison of sirolimus and tacrolimus.
181Pancreas transplants: experience with 232 percutaneous US-guided biopsy procedures in 88 patients.
182Decline in native renal function early after bladder-drained pancreas transplantation alone.
183Pancreas-after-kidney transplantation: an increasingly attractive alternative to simultaneous pancreas-kidney transplantation.
184Tolerance for immunosuppression in organ transplantation.
185Correlation of quantitative digital image analysis with the glomerular filtration rate in chronic allograft nephropathy.
186Measured and estimated GFR in healthy potential kidney donors.
187Histologic findings of antibody-mediated rejection in ABO blood-group-incompatible living-donor kidney transplantation.
188Living-donor kidney transplantation at Mayo Clinic--Rochester.
189Blood pressure evaluation among older living kidney donors.
190Overcoming a positive crossmatch in living-donor kidney transplantation.
191Accommodation in ABO-incompatible kidney allografts, a novel mechanism of self-protection against antibody-mediated injury.
192Influence of surveillance renal allograft biopsy on diagnosis and prognosis of polyomavirus-associated nephropathy.
193Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: results at three years.
194Improved scoring system to assess adult donors for cadaver renal transplantation.
195Kidney transplantation without calcineurin inhibitors using sirolimus.
196ABO-incompatible kidney transplantation using both A2 and non-A2 living donors.
197Gene expression during acute allograft rejection: novel statistical analysis of microarray data.
198Forskolin suppresses insulin gene transcription in islet beta-cells through a protein kinase A-independent pathway.
199Changes in intragraft gene expression secondary to ischemia reperfusion after cardiac transplantation.
200Chronic renal dysfunction late after liver transplantation.

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.