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Study Evaluating Sirolimus in the Treatment of Kidney Transplant

Primary Purpose

Kidney Failure, Kidney Diseases

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Sirolimus
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring Kidney Failure, Kidney Transplant, Graft Rejection, Kidney Transplantation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Renal transplantation Biopsy-confirmed chronic rejection Treatment with mofetil mycophenolate among cyclosporine or tacrolimus Exclusion Criteria: Transplant of any organ other than the kidney Current important infection Acute rejection within 12 weeks prior to inclusion

Sites / Locations

Outcomes

Primary Outcome Measures

Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus

Secondary Outcome Measures

Histological parameters at 12 months
Cumulative incidence of biopsy-confirmed acute rejection at 12 months
Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria

Full Information

First Posted
January 24, 2006
Last Updated
March 21, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00282217
Brief Title
Study Evaluating Sirolimus in the Treatment of Kidney Transplant
Official Title
Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Kidney Diseases
Keywords
Kidney Failure, Kidney Transplant, Graft Rejection, Kidney Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sirolimus
Primary Outcome Measure Information:
Title
Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus
Secondary Outcome Measure Information:
Title
Histological parameters at 12 months
Title
Cumulative incidence of biopsy-confirmed acute rejection at 12 months
Title
Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Renal transplantation Biopsy-confirmed chronic rejection Treatment with mofetil mycophenolate among cyclosporine or tacrolimus Exclusion Criteria: Transplant of any organ other than the kidney Current important infection Acute rejection within 12 weeks prior to inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Spain, infomed@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Albacete
ZIP/Postal Code
2006
Country
Spain
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
City
Granada
ZIP/Postal Code
18014
Country
Spain
City
L'Hospitalet de Llobregat
ZIP/Postal Code
8701
Country
Spain
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28035
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Sirolimus in the Treatment of Kidney Transplant

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