European Trial of Immunosuppression in SPK Tx

Sponsor

EUROSPK Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00140543

Collaborator

Fujisawa GmbH (Industry), Hoffmann-La Roche (Industry), Wyeth is now a wholly owned subsidiary of Pfizer (Industry), Neovii Biotech (Industry), Genzyme, a Sanofi Company (Industry)

228

Enrollment

Locations

43.9

Duration (Months)

16.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based immunosuppression (in conjunction with initial short-term steroids and polyclonal antibody administration) in Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation.
To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related complications and overimmunosuppression-associated complications, particularly under monitoring of the pharmacokinetic profile of all drugs administered.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1 Diabetic Nephropathy	Drug: sirolimus versus mycophenolate mofetil	Phase 3

Detailed Description

This will be a controlled, randomised study, to be performed in 15-20 pancreas transplantation centers throughout Europe. Patients will be randomised into one of two treatment groups. Group 1 will receive Tacrolimus and Mycophenolate Mofetil (= best group in EuroSPK001 trial). Group 2 will receive Tacrolimus and Sirolimus. Both groups will receive in association short-term corticosteroids and polyclonal antibody preparation. Patients will be randomly assigned to one of the 2 treatment groups in a 1:1 ratio before transplantation. The study will last 3 years, with a first interim analysis of the data at 6 months and a complete analysis at 1 year.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A European Multicenter Open-Label Randomised Trial to Evaluate the Efficacy and Safety of Sirolimus and Tacrolimus Compared to MMF and Tacrolimus With Short-Course Induction Therapy, Short-Term Steroids Application in de Novo SPK Transplanted Diabetic Patients

Study Start Date :

Feb 1, 2002

Actual Study Completion Date :

Sep 30, 2005

Outcome Measures

Primary Outcome Measures

At 1 year:Incidence of biopsy-proven (kidney) rejection episodes. []

Secondary Outcome Measures

SECONDARY ENDPOINTS: At 6 months and 1 year []
* Kidney/Pancreas function (at 6 months and 1 year): []
- Kidney function will be measured by: []
- S- creatinine []
- Creatinine clearance []
- Pancreas function will be measured by: []
- Fasting Glucose level (< 123 mg/dl) []
- HbA1C []
- Need for insulin therapy []
- Need for oral drugs []
* At 6 months and 1 year: []
- Patient and graft survival []
- Lipid profile []
- Infections []
- Side effects []
- Blood Pressure []
- Treatment failure for any reason, such as permanent discontinuation of a drug, graft loss or death. []
* % of steroid free patients: at 6 months and 1 year. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients, of 18 to 55 years of age, with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.
Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years).
Patient must have signed the Patient Informed Consent Form.
Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.

Exclusion Criteria:

Patient is pregnant or breastfeeding.
Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.
Patient has a positive T-cell crossmatch on the most recent serum specimen.
Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
Pancreatic duct occlusion technique .
Donor is older than 55 years of age.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitätsklinik	Innsbruck	Austria	6020
2	Cliniques Universitaires Saint Luc	Brussels	Belgium	1200
3	UZ Gent	Gent	Belgium	9000
4	UZ Gasthuisberg	Leuven	Belgium	3000
5	Institute for clinical and experimental medicine-IKEM	Prague	Czechia	14021
6	Charite Campus Virchow Klinikum	Berlin	Germany	13353
7	Knappschaftskrankenhaus	Bochum-Langendreer	Germany	44892
8	Goethe University	Frankfurt am Main	Germany	60590
9	Chirurgische Universitätsklinik	Freiburg	Germany	79111
10	Klinikum Grosshadern-University of Munich	Munich	Germany	81366
11	Klinikum Innenstadt der Universität München	Munich	Germany	90336
12	Tel Aviv Sourasky Medical Center	Tel Aviv	Israel	64239
13	Hospital Clinico	Barcelona	Spain	08036
14	Hôpital Cantonal de Geneve	Geneva	Switzerland	1211