Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

NCT00261820 | Completed Phase 4

• 1 other identifier: 0468E1-100194
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.

Conditions

Graft Rejection; Kidney Failure; Kidney Transplantation

Keywords

Kidney Transplant

Outcome Measures

Primary Outcomes (2)

• - Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-

• transplantation.

Secondary Outcomes (4)

• Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff

• criteria at 3, 6 and 12 Months following transplantation

• One year graft biopsy status

• Incidence of document infection

Interventions

tacrolimus DRUG

mycophenolate mofetil DRUG

methylprednisolone DRUG

prednisolone DRUG

sirolimus DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 and \< 65 years
• End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor
• Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant

You may not qualify if:

• Evidence of active systemic or localized major infection at the time of initial sirolimus administration
• Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
• Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Tacrolimus; Mycophenolic Acid; Methylprednisolone; Prednisolone; Sirolimus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Belgium, trials-BEL@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For France, infomedfrance@wyeth.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 5, 2005
• Study Completion: January 1, 2005
• Last Updated: May 19, 2006

Record last verified: 2006-05