Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection
NCT00133172 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2014-09-08
Summary
The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.
Conditions
- Kidney Transplantation
Interventions
- DRUG
-
IV
- DRUG
-
mycophenolate mofetil
IV
- DRUG
-
IV
Sponsors & Collaborators
-
Astellas Pharma Canada, Inc.
collaborator INDUSTRY -
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Astellas Pharma Canada, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-07-31
- Primary Completion
- 2007-03-31
- Completion
- 2007-03-31
Countries
- Canada
Study Locations
More Related Trials
-
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
NCT00617604 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
NCT00282568 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients
NCT00650468 ·Status: COMPLETED ·Phase: PHASE4
-
RituxiMab INDuction in Renal Transplantation
NCT01095172 ·Status: UNKNOWN ·Phase: PHASE4
-
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
NCT00321113 ·Status: COMPLETED ·Phase: PHASE3
-
Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant
NCT00596947 ·Status: TERMINATED ·Phase: PHASE4
-
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
NCT00885820 ·Status: COMPLETED ·Phase: PHASE4
-
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients
NCT02953873 ·Status: COMPLETED ·Phase: PHASE4
-
A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.
NCT01363752 ·Status: COMPLETED ·Phase: PHASE4
-
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
NCT00113269 ·Status: COMPLETED ·Phase: PHASE4
-
Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
NCT00296348 ·Status: COMPLETED ·Phase: PHASE3
-
Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients
NCT00306397 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
NCT02963103 ·Status: TERMINATED ·Phase: PHASE4
-
A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
NCT00510913 ·Status: COMPLETED ·Phase: PHASE4
-
Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
NCT03194321 ·Status: COMPLETED ·Phase: PHASE4
-
Steroid Withdrawal Immunosuppression After Renal Transplantation
NCT01550445 ·Status: UNKNOWN ·Phase: PHASE4
-
Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community Clinics
NCT00902980 ·Status: COMPLETED
-
24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients
NCT00555789 ·Status: TERMINATED ·Phase: PHASE2
-
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
NCT00903188 ·Status: UNKNOWN ·Phase: PHASE4
-
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
NCT00311311 ·Status: TERMINATED ·Phase: PHASE3
-
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
NCT02723591 ·Status: COMPLETED ·Phase: PHASE4
-
Th1, Th2 and Monokine Responses as Risk Factors of Renal Transplant Rejection
NCT00150891 ·Status: COMPLETED
-
Rituximab for Prevention of Rejection After Renal Transplantation
NCT00565331 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.
NCT00296309 ·Status: COMPLETED ·Phase: PHASE3
-
Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant
NCT00135694 ·Status: COMPLETED ·Phase: PHASE2