Minimizing Immunosuppression in Old for Old Kidney Transplantation

Kidney Transplantation Clinical Trial

— ESP-CNI  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912678
• Other study ID #: ESP-2004-1
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2009
• Last updated: June 2, 2009
• Start date: March 2002
• Est. completion date: October 2008

Study information

• Verified date: June 2009
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2008
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• MMF (Cellcept) and Steroids
Prograf was withdrawn completely after randomization, MMF and steroids were given.
• Tacrolimus (Prograf)
After randomization CellCept was withdrawn completely, low-dose tacrolimus was given.

Locations

Country	Name	City	State
Germany	Charite - Transplant Center - Virchow Clinic	Berlin
Germany	Charite- Transplant Center - Campus Mitte	Berlin
Germany	Transplant Center Cologne (Koeln-Mehrheim)	Cologne
Germany	University of Essen - Transplant Center	Essen
Germany	University of Luebeck, Transplant Center	Luebeck

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	Astellas Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute rejection rate		One year	No
Secondary	Graft function		One year	No