Minimizing Immunosuppression in Old for Old Kidney Transplantation (ESP-CNI)

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma GmbH
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00912678
First received: June 1, 2009
Last updated: June 2, 2009
Last verified: June 2009
  Purpose

Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the decreased injury threshold of older grafts may limit the benefits of transplantation in these patients. To compare favourable effects between low dose tacrolimus (LD-Tac) and mycophenolate-mofetil (MMF) in this patient population the investigators conducted a one year prospective multicenter randomized controlled trial. 90 kidney transplant recipients > 65 years with cadaveric grafts (> 65 years) from 5 centers were enrolled and received baseline immunosuppression with daclizumab induction (1 mg/kg) at day one and day 14, LD-Tac (trough level 5-8 µg/ml), MMF (1-2 g/d) and steroids. After three months, patients were centrally randomized either to MMF (1-2 g/d) and steroids (23 patients) or to LD-Tac and steroids. Follow-up visits were performed every 4 weeks up to one year. Protocol biopsies were performed after one year. The investigators' primary hypothesis is that the biopsy proven rejection rate in the MMF group is not significantly different compared to the LD-Tac group after one year. The investigators' secondary hypothesis is that graft function in the MMF group (reflected by the glomerular filtration rate and protocol biopsy result) is superior to the graft function in the LD-Tac group.


Condition Intervention Phase
Kidney Transplantation
Drug: MMF (Cellcept) and Steroids
Drug: Tacrolimus (Prograf)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial to Compare a Calcineurin Inhibitor Free Immunosuppression With a Low Dose Tacrolimus Based Immunosuppression in "Old for Old" Kidney Transplantation.

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Acute rejection rate [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Graft function [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: March 2002
Study Completion Date: October 2008
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MMF and Steroid Group
Group of Patients randomized to MMF and Steroid maintenance immunosuppression after 3 months (Tacrolimus withdrawal)
Drug: MMF (Cellcept) and Steroids
Prograf was withdrawn completely after randomization, MMF and steroids were given.
Other Names:
  • Prograf
  • CellCept
Active Comparator: Low-Dose Tacrolimus Group
Patients randomized to withdrawal of MMF after 3 months and maintenance immunosuppression with low-dose tacrolimus and Steroids
Drug: Tacrolimus (Prograf)
After randomization CellCept was withdrawn completely, low-dose tacrolimus was given.
Other Name: Prograf

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receiving a cadaveric kidney transplant (first or re-transplant)
  • Patients must met the criteria of the EUROTRANSPLANT program
  • Organ allocation with the framework of EUROPEAN SENIOR PROGRAM (ESP) by EUROTRANSPLANT
  • Written consent

Exclusion Criteria:

  • Not fulfilled inclusion criteria
  • Cadaveric kidney from "non heart beating donors"
  • One or more than one steroid resistant acute rejections within the first 3 weeks after transplantation
  • Two or more than two steroid sensitive rejections (more than 2 administered steroid boli) within the first 3 weeks after transplantation
  • Tacrolimus trough level > 10ng/ml in three consecutive measurements
  • Allergy against macrolide antibiotics or tacrolimus
  • Systemic steroid therapy at study entry not related to transplantation
  • History of Malignancy
  • Clinical relevant uncontrolled infections, heavy diarrhea, vomiting or active ulcer disease
  • Patients who are enrolled in other clinical studies or were enrolled in other clinical studies 28 days before transplantation
  • Patients under medication not approved by the German Ministry of Health
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912678

Locations
Germany
Charite - Transplant Center - Virchow Clinic
Berlin, Germany, 13353
Charite- Transplant Center - Campus Mitte
Berlin, Germany, 10117
Transplant Center Cologne (Koeln-Mehrheim)
Cologne, Germany, 51109
University of Essen - Transplant Center
Essen, Germany
University of Luebeck, Transplant Center
Luebeck, Germany, 23562
Sponsors and Collaborators
University of Luebeck
Astellas Pharma GmbH
Investigators
Principal Investigator: Lutz Fricke, MD, PhD University of Luebeck
  More Information

Publications:
Responsible Party: Prof. Dr. Lutz Fricke, MD PhD, University of Luebeck Medical School, Medical Clinic I, Transplant Center
ClinicalTrials.gov Identifier: NCT00912678     History of Changes
Other Study ID Numbers: ESP-2004-1
Study First Received: June 1, 2009
Last Updated: June 2, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University of Luebeck:
Kidney transplantation
Old for old kidney transplantation
European senior program
Calcineurin inhibitor free immunosuppression

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014