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Trial record 1 of 1 for:    NCT00140543
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European Trial of Immunosuppression in SPK Tx

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ClinicalTrials.gov Identifier: NCT00140543
Recruitment Status : Unknown
Verified August 2005 by EUROSPK Study Group.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2005
Last Update Posted : November 18, 2005
Sponsor:
Collaborators:
Fujisawa GmbH
Hoffmann-La Roche
Wyeth is now a wholly owned subsidiary of Pfizer
Neovii Biotech
Genzyme, a Sanofi Company
Information provided by:
EUROSPK Study Group

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 1, 2005
Last Update Posted Date November 18, 2005
Study Start Date  ICMJE February 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
At 1 year:Incidence of biopsy-proven (kidney) rejection episodes.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE European Trial of Immunosuppression in SPK Tx
Official Title  ICMJE 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
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 1
  • Diabetic Nephropathy
Intervention  ICMJE Drug: sirolimus versus mycophenolate mofetil
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: August 31, 2005)
228
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Czech Republic,   Germany,   Israel,   Spain,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00140543
Other Study ID Numbers  ICMJE EUROSPK002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE EUROSPK Study Group
Collaborators  ICMJE
  • Fujisawa GmbH
  • Hoffmann-La Roche
  • Wyeth is now a wholly owned subsidiary of Pfizer
  • Neovii Biotech
  • Genzyme, a Sanofi Company
Investigators  ICMJE
Study Chair: Jean-Paul Squifflet, MD,PhD SPEAKER FOR THE EUROSPK STUDY GROUP
PRS Account EUROSPK Study Group
Verification Date August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP