Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00137345 |
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Recruitment Status :
Terminated
First Posted : August 29, 2005
Last Update Posted : February 8, 2013
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Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
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Brief Summary:
The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Transplant | Drug: sirolimus | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients |
| Study Start Date : | June 2005 |
| Actual Primary Completion Date : | August 2006 |
| Actual Study Completion Date : | August 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Sirolimus
Primary Outcome Measures :
- To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
- Non-inferiority of the composite of graft loss and death at 52 weeks
Secondary Outcome Measures :
- Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
- quality of life at 24, 52 and 104 weeks
Information from the National Library of Medicine
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Dialysis patients who will be receiving their first kidney transplant
- Weight over 88 pounds (lbs.)
Exclusion Criteria:
- Very high cholesterol levels
- Obesity
- Organ donor over 65 years of age if living; over 60 years of age if cadaveric.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137345
Locations
Show 82 study locations
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 Germany, MedInfoDEU@wyeth.com | |
| Principal Investigator: | Trial Manager | For Norway, Sweden, MedInfoNord@wyeth.com | |
| Principal Investigator: | Trial Manager | For Australia, Taiwan, medinfo@wyeth.com | |
| Principal Investigator: | Trial Manager | For Austria, WPVIMED@wyeth.com | |
| Principal Investigator: | Trial Manager | For Italy, Greece, decresg@wyeth.com | |
| Principal Investigator: | Trial manager | For Hungary, WPBUMED@wyeth.com | |
| Principal Investigator: | Trial Manager | For Turkey, Erisc@wyeth.com | |
| Principal Investigator: | Trial Manager | For South Africa, ZAFinfo@wyeth.com | |
| Principal Investigator: | Trial Manager | For Argentina, Chile, scheima@wyeth.com, rendop@wyeth.com | |
| Principal Investigator: | Trial Manager | For UK, ukmedonfo@wyeth.com | |
| Principal Investigator: | Trial Manager | For Switzerland, med@wyeth.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00137345 |
| Other Study ID Numbers: |
0468H1-318 B1741188 ( Other Identifier: Pfizer ) |
| First Posted: | August 29, 2005 Key Record Dates |
| Last Update Posted: | February 8, 2013 |
| Last Verified: | September 2006 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
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Randomized controlled trial Clinical Trial Phase III Drug therapy Immunosuppression |
Treatment outcome Kidney transplantation Kidney function tests |
Additional relevant MeSH terms:
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Sirolimus Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antineoplastic Agents |
Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |