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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sirolimus vs Mycophenolate With Tacrolimus in Simultaneous Pancreas and Kidney Transplantation

NCT03582878

Diabetes Mellitus, Type 1

COMPLETED PHASE4

Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients

NCT00266123

Graft Rejection Kidney Failure Kidney Transplant

COMPLETED PHASE4

European Trial of Immunosuppression in SPK Tx

NCT00140543

Diabetes Mellitus, Type 1 Diabetic Nephropathy

COMPLETED PHASE3

The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients

NCT00275535

Kidney Diseases

COMPLETED PHASE4

Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

NCT00519116

Kidney Transplantation

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreas Transplantation Kidney Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

In a first period, the patient will receive Tacrolimus. The time of first administration will be within the first 48H post transplantation.

In a second period, the patient will receive Sirolimus. The time of first administration of Sirolimus will be between day 60 and day 90 post transplant. Tacrolimus will be stopped at that time.

Group Type OTHER

Sirolimus

Intervention Type DRUG

In a first period, the patient will receive Tacrolimus. The time of first administration will be within the first 48H post transplantation. The initial dose will be 0,1 mg/day po. then titrated to maintain trough whole-blood concentrations between 5-15 ng/ml.

In a second period, the patient will receive Sirolimus. The time of first administration of Sirolimus will be between day 60 and day 90 post transplant. Tacrolimus will be stopped at that time.

The initial dose will be 8 mg/day po. till a trough level is obtained and then titrated to maintain trough whole-blood concentrations between 5-15ng/ml.

The dose of sirolimus will be administrated once a day.

1

Patients receive Tacrolimus from day 0 to the end of the study (Arm Tacrolimus).

Group Type OTHER

Tacrolimus

Intervention Type DRUG

Patients receive Tacrolimus from day 0 to the end of the study. The time of first administration will be within the first 48 hours post transplant.

The dose of tacrolimus will be administrated twice a day. The initial dose will be 0,1 mg/day po. then titrated to maintain trough whole-blood concentrations between 5-15 ng/ml.

Patients receive also rATG , mycophenolate mofetil and corticosteroids.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sirolimus

In a first period, the patient will receive Tacrolimus. The time of first administration will be within the first 48H post transplantation. The initial dose will be 0,1 mg/day po. then titrated to maintain trough whole-blood concentrations between 5-15 ng/ml.

In a second period, the patient will receive Sirolimus. The time of first administration of Sirolimus will be between day 60 and day 90 post transplant. Tacrolimus will be stopped at that time.

The initial dose will be 8 mg/day po. till a trough level is obtained and then titrated to maintain trough whole-blood concentrations between 5-15ng/ml.

The dose of sirolimus will be administrated once a day.

Intervention Type DRUG

Tacrolimus

Patients receive Tacrolimus from day 0 to the end of the study. The time of first administration will be within the first 48 hours post transplant.

The dose of tacrolimus will be administrated twice a day. The initial dose will be 0,1 mg/day po. then titrated to maintain trough whole-blood concentrations between 5-15 ng/ml.

Patients receive also rATG , mycophenolate mofetil and corticosteroids.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Recipient age ≥ 18 and ≤ 60 years.
* Patients receiving a first cadaveric simultaneous pancreas-kidney transplant for insulin-dependent diabetes associated with end-stage renal disease.
* Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation.
* Signed and dated informed consent.

Exclusion Criteria

* Donor age ≤ 15 years and ≥ 60 years.
* Evidence of active systemic or localized major infection.
* Evidence of infiltrate, cavitation, or consolidation on chest x-ray.
* Use of any investigational drug or treatment (in particular immuno-suppressive drugs) up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase.
* History of malignancy (with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence within 5 years of enrolment into the study).
* Graft from a living donor.
* Double renal graft.
* Pregnancy.
* Known hypersensitivity to sirolimus and its derivatives or to tacrolimus.
* Known hypersensitivity to rabbit's proteins.
* Multiple organ transplants or recipients of previously transplanted organs other than kidney.
* Treatment with cisapride (PrépulsidÒ), pimozide (OrapÒ), ketoconazole (NizoralÒ), fluconazole (TriflucanÒ) or millepertuis (ProcalmilÒ, Arkogélules MillepertuisÒ), that is not discontinued within 24 hours prior to transplant.
* Total white blood cell count ≤ 2 x 109/L or platelet count ≤ 70.000/mm3 at baseline.
* Patients with evidence of active histological or biological hepatic disease during the six months period before the transplantation.
* HIV positive recipients.
* Non-heart beating donor.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No