ESP-CNI: Minimizing Immunosuppression in Old for Old Kidney Transplantation
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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Prograf was withdrawn completely after randomization, MMF and steroids were given.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:
|
| 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After randomization CellCept was withdrawn completely, low-dose tacrolimus was given.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 Names:
|
Outcome Measures
Primary Outcome Measures
- Acute rejection rate [One year]
Secondary Outcome Measures
- Graft function [One year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients receiving a cadaveric kidney transplant (first or re-transplant)
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Patients must met the criteria of the EUROTRANSPLANT program
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Organ allocation with the framework of EUROPEAN SENIOR PROGRAM (ESP) by EUROTRANSPLANT
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Written consent
Exclusion Criteria:
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Not fulfilled inclusion criteria
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Cadaveric kidney from "non heart beating donors"
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One or more than one steroid resistant acute rejections within the first 3 weeks after transplantation
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Two or more than two steroid sensitive rejections (more than 2 administered steroid boli) within the first 3 weeks after transplantation
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Tacrolimus trough level > 10ng/ml in three consecutive measurements
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Allergy against macrolide antibiotics or tacrolimus
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Systemic steroid therapy at study entry not related to transplantation
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History of Malignancy
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Clinical relevant uncontrolled infections, heavy diarrhea, vomiting or active ulcer disease
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Patients who are enrolled in other clinical studies or were enrolled in other clinical studies 28 days before transplantation
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Patients under medication not approved by the German Ministry of Health
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charite- Transplant Center - Campus Mitte | Berlin | Germany | 10117 | |
| 2 | Charite - Transplant Center - Virchow Clinic | Berlin | Germany | 13353 | |
| 3 | Transplant Center Cologne (Koeln-Mehrheim) | Cologne | Germany | 51109 | |
| 4 | University of Essen - Transplant Center | Essen | Germany | ||
| 5 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Ducloux D, Motte G, Billerey C, Bresson-Vautrin C, Vautrin P, Rebibou JM, Saint-Hillier Y, Chalopin JM. Cyclosporin withdrawal with concomitant conversion from azathioprine to mycophenolate mofetil in renal transplant recipients with chronic allograft nephropathy: a 2-year follow-up. Transpl Int. 2002 Sep;15(8):387-92. Epub 2002 Aug 21.
- Friemann S, Feuring E, Padberg W, Ernst W. Improvement of nephrotoxicity, hypertension, and lipid metabolism after conversion of kidney transplant recipients from cyclosporine to tacrolimus. Transplant Proc. 1998 Jun;30(4):1240-2.
- Pohanka E, Bechstein WO, Berlakovich G, Binet I, Friemann S, Heemann U, Kliem V, Sperschneider H, Stangl M, Ringe B. [Dosage and monitoring of tacrolimus after kidney transplantation]. Dtsch Med Wochenschr. 2000 May 12;125(19):608-11. Review. German.
- Vincenti F, Kirkman R, Light S, Bumgardner G, Pescovitz M, Halloran P, Neylan J, Wilkinson A, Ekberg H, Gaston R, Backman L, Burdick J. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplantation. Daclizumab Triple Therapy Study Group. N Engl J Med. 1998 Jan 15;338(3):161-5.
- ESP-2004-1