European Trial of Immunosuppression in SPK Tx

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00140543
• Other study ID #: EUROSPK002
• Status: Completed
• Phase: Phase 3
• Start date: February 2002
• Est. completion date: September 30, 2005

Study information

• Verified date: August 2021
• Source: EUROSPK Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. 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.

2. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: September 30, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Male or female patients, of 18 to 55 years of age, with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.

2. 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).

3. Patient must have signed the Patient Informed Consent Form.

4. 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:

1. Patient is pregnant or breastfeeding.

2. Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.

3. Patient has a positive T-cell crossmatch on the most recent serum specimen.

4. 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.

5. Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.

6. Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.

7. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.

8. Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.

9. Pancreatic duct occlusion technique .

10. Donor is older than 55 years of age.

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Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetic Nephropathies
• Diabetic Nephropathy

Intervention

Drug:
• sirolimus versus mycophenolate mofetil

Locations

Country	Name	City	State
Austria	Universitätsklinik	Innsbruck
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	UZ Gent	Gent
Belgium	UZ Gasthuisberg	Leuven
Czechia	Institute for clinical and experimental medicine-IKEM	Prague
Germany	Charite Campus Virchow Klinikum	Berlin
Germany	Knappschaftskrankenhaus	Bochum-Langendreer
Germany	Goethe University	Frankfurt am Main
Germany	Chirurgische Universitätsklinik	Freiburg
Germany	Klinikum Grosshadern-University of Munich	Munich
Germany	Klinikum Innenstadt der Universität München	Munich
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Spain	Hospital Clinico	Barcelona
Switzerland	Hôpital Cantonal de Geneve	Geneva

Sponsors (6)

Lead Sponsor	Collaborator
EUROSPK Study Group	Fujisawa GmbH, Genzyme, a Sanofi Company, Hoffmann-La Roche, Neovii Biotech, Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Germany,  Israel,  Spain,  Switzerland, 

Outcome

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