NCT00140543

Brief Summary

  1. 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. 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2002

Typical duration for phase_3

Geographic Reach
7 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2005

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

First QC Date

August 31, 2005

Last Update Submit

August 17, 2021

Conditions

Diabetes Mellitus, Type 1Diabetic Nephropathy

Keywords

simultaneous pancreas/kidney transplantationImmunosuppression

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (18)

  • 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

  • +13 more secondary outcomes

Interventions

sirolimus versus mycophenolate mofetilDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Universitätsklinik

Innsbruck, 6020, Austria

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

Institute for clinical and experimental medicine-IKEM

Prague, 14021, Czechia

Location

Charite Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Goethe University

Frankfurt am Main, 60590, Germany

Location

Chirurgische Universitätsklinik

Freiburg im Breisgau, 79111, Germany

Location

Knappschaftskrankenhaus

Langendreer, 44892, Germany

Location

Klinikum Grosshadern-University of Munich

Munich, 81366, Germany

Location

Klinikum Innenstadt der Universität München

Munich, 90336, Germany

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Hospital Clinico

Barcelona, 08036, Spain

Location

Hôpital Cantonal de Geneve

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes Complications

Study Officials

  • Jean-Paul Squifflet, MD,PhD

    SPEAKER FOR THE EUROSPK STUDY GROUP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

February 1, 2002

Study Completion

September 30, 2005

Last Updated

August 23, 2021

Record last verified: 2021-08

Locations

ES(1)CH(1)CZ(1)AU(1)DE(6)BE(3)IL(1)