Study Evaluating Sirolimus in the Treatment of Kidney Transplant
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00282217
Collaborator
(none)
100
13
7.7
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy
Study Start Date
:
Aug 1, 2006
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Albacete | Spain | 2006 | ||
| 2 | Barcelona | Spain | 8035 | ||
| 3 | Cadiz | Spain | 11009 | ||
| 4 | Granada | Spain | 18014 | ||
| 5 | L'Hospitalet de Llobregat | Spain | 8701 | ||
| 6 | La Coruna | Spain | 15006 | ||
| 7 | Madrid | Spain | 28034 | ||
| 8 | Madrid | Spain | 28035 | ||
| 9 | Madrid | Spain | 28040 | ||
| 10 | Malaga | Spain | 29010 | ||
| 11 | Oviedo | Spain | 33006 | ||
| 12 | Sevilla | Spain | 41013 | ||
| 13 | Zaragoza | Spain | 50009 |
Sponsors and Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
- Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
- Principal Investigator: Trial Manager, For Spain, infomed@wyeth.com
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00282217
Other Study ID Numbers:
- 101467
First Posted:
Jan 25, 2006
Last Update Posted:
Mar 22, 2007
Last Verified:
Mar 1, 2007
Keywords provided by ,
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Additional relevant MeSH terms: