Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

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NCT00261820

Last updated on November 9, 2019

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About this Study

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.

Study Location

Contact

1-800-718-1021

[email protected]

Eligibility criteria

Condition

Graft Rejection, Kidney Failure, Kidney Transplantation

Sex

Females and Males

Age

18-65 years

Inclusion criteria

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- Age: 18 and

- 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

Exclusion criteria

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- 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

NCT00261820

Pfizer

Completed

Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

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Descriptive Information

Brief Title ^ICMJE

Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Official Title ^ICMJE

A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Tacrolimus Plus Mycophenolate Mofetil Plus Corticosteroids

Brief Summary

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Graft Rejection
Kidney Failure
Kidney Transplantation

Intervention ^ICMJE

Drug: tacrolimus
Drug: mycophenolate mofetil
Drug: methylprednisolone
Drug: prednisolone
Drug: sirolimus

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

160

Original Enrollment ^ICMJE

Same as current

Study Completion Date ^ICMJE

January 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 65 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00261820

Other Study ID Numbers ^ICMJE

0468E1-100194

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For Belgium, [email protected]
Principal Investigator:	Trial Manager	For France, [email protected]

PRS Account

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

May 2006

^ICMJE Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

NCT00261820

About this Study

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Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

NCT00261820

About this Study

NEED INFO?

Try a new search

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