Phase 2 N=40 Belatacept Post Depletional Repopulation to Facilitate Tolerance
Organ Transplantation
Primary: Number of Patients Successfully Withdrawn From Oral Immunosuppression — 12; 7 Participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=383 Everolimus in de Novo Kidney Transplant Recipients
Kidney Transplantation
Primary: Percentage of Participants Without Wound Healing Complications - Worst-case Scenario — 68.39; 61.58 Percentage of participants — p=0.0921
Phase 4 N=181 Everolimus in de Novo Heart Transplant Recipients
Cardiac Transplantation
Primary: Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group — 40; 30 participants — p=0.1043
Phase 4 N=6 Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients
Nephrotoxicity
Primary: Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) — 2.25 ml/min/1.73m2
Phase 3 N=32 Tacrolimus/Everolimus Versus Tacrolimus/Enteric-Coated Mycophenolate Sodium
Transplant; Failure, Kidney
Primary: BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant — 1; 3 participants — p=0.32
Phase 2 N=26 Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant
Kidney Transplant
Primary: Number of Subjects With Antibody-Mediated Rejection (AMR) in the First 3 Months After Living Donor Kidney Transplantation — 2 Participants
Phase 2 N=12 Sirolimus and Thymoglobulin to Prevent Kidney Transplant Rejection
Kidney Failure
Primary: Serum Creatinine Concentration — 112 umol/L
Phase 4 N=10 Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
End Stage Renal Disease · Hepatitis C
Primary: Viral Response at Week 12 — 10 Participants
Phase 4 N=122 Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant
Hepatitis C · Transplantation Disease Transmission
Primary: Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ) — 23 Participants
Phase 3 N=13 Belatacept Therapy for the Failing Renal Allograft
Failing Renal Allograft
Primary: Number of Participants With Donor-specific Antibody Formation — 3; 4 Participants
Phase 2 N=31 Combination Drug Therapy Followed by Single Drug Steroid Free Therapy to Prevent Organ Rejection in Kidney Transplantation
Kidney Transplantation
Primary: The Rate of Allograft Rejection — 0; 0 participants
Phase 4 N=10 Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors
End Stage Renal Disease · Hepatitis C
Primary: Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA — 10 Participants
Phase 1 N=2 Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)
Kidney Failure, Chronic · Renal Insufficiency
Primary: Number of Participants With Successful Withdrawal of Immunosuppression — 2 Participants
Phase 3 N=802 Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen
Kidney Transplantation
Primary: GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen — 63.03; 68.59; 63.08 ml/min/1.73m² — p=< 0.0001
Phase 2 N=323 A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
Kidney Transplantation
Primary: Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review — 12.7; 26.3; 18.8; 16.7 percentage of participants
Phase 3 N=114 Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
Organ Transplantation, Renal Transplantation
Primary: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula) — 68.5; 69.2; 63.6; 68.3 mL/min per 1.73 m^2
Phase 2 N=527 Calcineurin Inhibitor Sparing After Kidney Transplantation
CNI Side Effects
Primary: Phase I: The Minimization of Negative Side Effects - Patient Survival — 99; 98 percentage of participants
Phase 3 N=109 Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
Heart Diseases · Heart Transplantation
Primary: The Change in the Markers of Growth, Apoptosis, Inflammation and Oxidation Measured in Endomyocardial Biopsies — 0.70; 0.90; 0.87; 0.79 Densitometry / Densitometry of…
N/A N=40 Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens
End Stage Renal Failure With Renal Transplant
Primary: Change in T Cell & B Cell Generation — 1.05; 0.93; 0.8; 1.12 Mean % of Treg cells in peripheral blood
Phase 3 N=70 De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma
Liver Carcinoma
Primary: Percentage of Participants Surviving at One and Four Years After Liver Transplant — 85; 77 percentage of participants
Phase 2 N=2 Renal Allograft Tolerance Through Mixed Chimerism
End Stage Renal Disease
Primary: Successful Withdrawal of Immunosuppressive Therapy — 2 Participants
Phase 2 N=5 Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection
Kidney Transplantation · Kidney Failure, Chronic
Primary: Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks — 3 participants
Phase 3 N=446 A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
Kidney Transplantation
Primary: Percentage of Participants Who Survive With a Functional Graft at 24 Months — 98.2; 97.3 Percentage
Phase 4 N=36 Dosing Strategies for de Novo Once-daily Extended Release Tacrolimus (LCPT) in Kidney Transplant Recipients
Kidney Transplant
Primary: Time to First Therapeutic Tacrolimus Trough Concentration From Initiation of Tacrolimus Extended Release Measured in Days — 4.5; 6; 13.5 days
N/A N=30 Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant
Liver Transplantation
Primary: Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery — 72; 87.8; 51.0 mL/min
Phase 4 N=8 Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Renal Failure
Primary: Number of Participants With Undetectable HCV RNA at SVR12 — 8 Participants
Phase 4 N=180 Improved Induction and Maintenance Immunosuppression in Kidney Transplantation
End-stage Renal Disease
Primary: Chronic Allograft Nephropathy (Cumulative Calcineurin-inhibitor Nephrotoxicity/Transplant Nephropathy) Per Protocol Surveillance Kidney Biopsies (Banff Grading…
Phase 2 N=13 A Dose Escalation Study in de Novo Renal Transplantation
Kidney Transplantation
Primary: Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. — 2; 4; 7; 0 Participants
Phase 4 N=29 Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)
Kidney Transplant · Diabetes Mellitus, Type 2 · Diabetic Nephropathy
Primary: Freedom From Insulin Therapy Post Transplant — 3; 4 Participants
Phase 2 N=10 Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
Kidney Transplantation · Kidney Disease
Primary: Number of Acute Rejections in All Enrolled Participants — 1 Rejection Events