Phase 3 N=28 Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection
Kidney Diseases
Primary: Stimulation of Growth After 12 Months (Delta Z-score) — 1.2; 0.6 units on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=106 Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients
Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant
Primary: Number of Participants Having Reached the Composite Efficacy Endpoint of Biopsy-proven Acute Rejection — 5; 3; 5; 5 Participants — p=0.9712
Phase 2 N=130 Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation
Kidney Diseases · Kidney Transplantation · Kidney Transplant
Primary: The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation — 0.37; 0.35 Standard Deviation Score (SDS) — p=0.79
Phase 3 N=77 Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Liver Transplantation · Infection
Primary: Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation — 8; 15…
Phase 1 N=20 Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients
Liver Transplant · Liver Transplantation
Primary: Proportion of Participants Successfully Withdrawn From Immunosuppression — 0.60 Proportion of participants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=12 Sirolimus and Thymoglobulin to Prevent Kidney Transplant Rejection
Kidney Failure
Primary: Serum Creatinine Concentration — 112 umol/L
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 3 N=56 Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.
Renal Function · Liver Transplant
Primary: Change From Baseline in Estimated Glomerular Filtration Rate - Month 12 — 6.2 mL/min/1.73m^2
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
N/A N=30 DBS for Home Monitoring in Children With Kidney Transplantation
Kidney Disease
Primary: Variability of Tacrolimus Blood Levels Measured by DBS Over Time — 2.635 ng/ml
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 2 N=35 Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients
Kidney Failure, Chronic · Kidney Transplantation · Immunosuppression
Primary: The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation — 0.057 Proportion of participants
N/A N=50 Perioperative Aminophylline to Improve Early Kidney Function After a Kidney Transplant
Function of Renal Transplant
Primary: Calculated Estimated Glomerular Filtration Rate (eGFR) — 67.39; 80.48 ml/min/1.73m2 — p=0.32
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 2 N=23 Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation
Evidence of Liver Transplantation · Rejection · ALEMTUZUMAB
Primary: Incidence of Post Transplant Lymphoproliferative Disorder (PTLD) — 6 participants
N/A N=30 A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf
Acute Graft Rejection · Diabetes
Primary: Number of Participants With New Onset Diabetes After Transplant (NODAT) or Acute Rejection — 2; 2 Participants
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 2 N=40 Belatacept Post Depletional Repopulation to Facilitate Tolerance
Organ Transplantation
Primary: Number of Patients Successfully Withdrawn From Oral Immunosuppression — 12; 7 Participants
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 2 N=19 A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
Liver Transplantation
Primary: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus — 198.2; 193.0 ng*hr/mL
N/A N=44 Low Dose Thymoglobin in Renal Transplant Patients
Acute Renal Failure
Primary: Rates of Acute Cellular Rejection Between Study Group — 4; 2 Number of rejection — p=<0.05
Phase 4 N=77 Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children
Nephrotic Syndrome
Primary: Remission Rate — 34; 13 Participants — p=0.001
N/A N=169 Intervention to Improve Adherence in Teen Kidney Transplant
Kidney Transplantation · Medication Adherence
Primary: Taking Adherence — 78; 68 % of days with 100% taking adherence — p=0.006
Phase 2 N=88 Immunosuppression Withdrawal for Stable Pediatric Liver Transplant Recipients
Liver Transplant Recipients · Liver Transplantation · Immunosuppression
Primary: Number of Operationally Tolerant Participants — 33 Participants
Phase 4 N=200 Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols
Transplant; Failure, Kidney
Primary: Incidence of Acute Rejection at One Year Post-transplant — 14; 13 percentage of patients having BPAR
Phase 2 N=58 Regimen Optimization Study
Kidney Transplantation
Primary: Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months — 7.7; 9.4 Percentage of participants
Phase 1 N=16 Subcutaneous Abatacept in Renal Transplant Recipients
Kidney Transplant Recipient
Primary: Number of Participants Who Are Compliant With Self-administration — 8; 5; 1 Participants
Phase 4 N=20 Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure
Kidney Transplant
Primary: Graft Survival — 13; 7 participants — p=0.849
Phase 2 N=331 Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
Kidney Transplantation
Primary: Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant — 9; 11; 7 participants