European Trial of Immunosuppression in SPK Tx

August 17, 2021 updated by: EUROSPK Study Group

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

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

228

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Universitätsklinik
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Gent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • Uz Gasthuisberg
  • Czechia
      • Prague, Czechia, 14021
        • Institute for clinical and experimental medicine-IKEM
  • Germany
      • Berlin, Germany, 13353
        • Charite Campus Virchow Klinikum
      • Bochum-Langendreer, Germany, 44892
        • Knappschaftskrankenhaus
      • Frankfurt am Main, Germany, 60590
        • Goethe University
      • Freiburg, Germany, 79111
        • Chirurgische Universitätsklinik
      • Munich, Germany, 81366
        • Klinikum Grosshadern-University of Munich
      • Munich, Germany, 90336
        • Klinikum Innenstadt der Universität München
  • Israel
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinico
  • Switzerland
      • Geneva, Switzerland, 1211
        • Hopital Cantonal de Genève

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
At 1 year:Incidence of biopsy-proven (kidney) rejection episodes.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EUROSPK Study Group

Collaborators

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

Investigators

  • Study Chair: Jean-Paul Squifflet, MD,PhD, SPEAKER FOR THE EUROSPK STUDY GROUP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Completion (Actual)

September 30, 2005

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUROSPK002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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