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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00912678
First Posted: June 3, 2009
Last Update Posted: June 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma GmbH
Information provided by:
University of Luebeck
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Graft function [ Time Frame: One year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912678


Locations
Germany
Charite- Transplant Center - Campus Mitte
Berlin, Germany, 10117
Charite - Transplant Center - Virchow Clinic
Berlin, Germany, 13353
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
First Submitted: June 1, 2009
First Posted: June 3, 2009
Last Update Posted: June 3, 2009
Last Verified: June 2009

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

Additional relevant MeSH terms:
Tacrolimus
Calcineurin Inhibitors
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents