A Study To Compare Sirolimus Versus Tacrolimus In De Novo Simultaneous Pancreas- Kidney Allograft Recipients Receiving An Induction Therapy With Antithymocyte Globulin Plus Mycophenolate Mofetil Plus Corticosteroids

Kidney Transplantation Clinical Trial

Official title:
An Open-Label, Comparative, Randomized, Prospective Study To Compare Sirolimus Versus Tacrolimus In De Novo Simultaneous Pancreas- Kidney Allograft Recipients Receiving An Induction Therapy With Antithymocyte Globulin Plus Mycophenolate Mofetil Plus Corticosteroids

Status Active, not recruiting

Clinical Trial Summary

Experience with tacrolimus in pancreas transplantation has become a standard for immunosuppression in almost all pancreas centers over the world. Several centers have shown very good results in simultaneous pancreas-kidney (SPK) transplant recipients receiving antithymocyte globulin induction and maintenance immunosuppression consisting of calcineurin inhibitor and mycophenolate mofetil with or without corticosteroids.

The use of sirolimus in SPK transplant patients has for the moment only been studied, with good results, in association with tacrolimus or cyclospsorine (CsA). In renal transplantation, there is also evidence that sirolimus (Rapamune) is a potent immunosuppressant that significantly reduces the incidence of acute rejection when given with CsA, effective as base therapy in the post-induction period. Because of Rapamune's effectiveness and different safety profile, it might be advantageous in terms of reduced nephrotoxicity to avoid completely calcineurin inhibitors without increased incidence of acute rejection.

To explore this further, the following study is designed to assess the use of SRL versus TAC, both treatment groups including rATG plus MMF and a 3-month course of steroids in de novo simultaneous pancreas-kidney transplant recipients.

Clinical Trial Description

The main objective is to compare renal and pancreas graft survivals at 12 months after simultaneous pancreas-kidney transplantation in patients receiving either a regimen combining sirolimus (SRL) plus mycophenolate mofetil (MMF) following an antibody induction (rATG) or a regimen combining tacrolimus (TAC) plus mycophenolate mofetil following an antibody induction (rATG). In both regimens corticosteroids (CS) will be withdrawn three months after transplantation.

In addition, the two treatment groups will be compared for acute rejection, renal and pancreas functions and patient survival after transplantation at 12 months and for a total period of 5 years of follow-up. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00693446
Study type	Interventional
Source	Nantes University Hospital
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	April 2004
Completion date	April 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04910867` - APOL1 Genetic Testing Program for Living Donors	N/A
Completed	`NCT02723591` - 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	Phase 4
Completed	`NCT05945511` - Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
Completed	`NCT02234349` - Bile Acids and Incretins in Pancreas Kidney Transplant Patients	N/A
Completed	`NCT04496401` - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus	Phase 4
Recruiting	`NCT05917795` - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates	N/A
Not yet recruiting	`NCT05934383` - Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension	N/A
Withdrawn	`NCT04936971` - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response	Phase 4
Not yet recruiting	`NCT04540640` - Oxygenated Machine Preservation in Kidney Transplantation	N/A
Not yet recruiting	`NCT03090828` - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease	N/A
Recruiting	`NCT02908139` - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients	N/A
Completed	`NCT02560558` - Bela 8 Week Dosing	Phase 4
Terminated	`NCT02417870` - Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation	Phase 1/Phase 2
Recruiting	`NCT02154815` - Pre-emptive Kidney Transplantation Quality of Life	N/A
Completed	`NCT02235571` - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients	N/A
Enrolling by invitation	`NCT01905514` - ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients	N/A
Completed	`NCT02147210` - Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1	N/A
Recruiting	`NCT01699360` - The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients	Phase 4
Completed	`NCT01672957` - ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil)	N/A
Completed	`NCT01655563` - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation	Phase 2