Study Evaluating Sirolimus in Kidney Transplant Recipients.
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00167947
First received: September 9, 2005
Last updated: March 13, 2008
Last verified: March 2008
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Purpose
Renal function at 12 months assessed by calculated creatinine clearance.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Failure Graft vs Host Disease |
Drug: Cyclosporine Drug: Steroids Drug: Rapamune (Sirolimus) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open Label Study to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients. |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2005 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: Cyclosporine
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Drug: Steroids
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Drug: Rapamune (Sirolimus)
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
|
| Experimental: B |
Drug: Cyclosporine
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Drug: Steroids
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
Drug: Rapamune (Sirolimus)
Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age is older than 18 years.
- End-stage renal disease, with subjects scheduled for kidney transplant.
- Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.
Other inclusion applies.
Exclusion Criteria:
- Evidence of active systemic or localized major infection.
- Use of any investigational drug or treatment up to 4 weeks prior to study entry.
- Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, basiliximab.
- Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).
- Immunosuppression therapies other than those allowed in the protocol.
- Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (all known to interact with SRL) that is not discontinued prior to study entry.
Other exclusion applies.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167947
Locations
| Italy | |
| Roma, Lazio, Italy, 00168 | |
| Roma, Lazio, Italy, 00144 | |
| Palermo, Sicily, Italy, 90127 | |
| Bari, Italy, 70100 | |
| Bologna, Italy, 40138 | |
| Cagliari, Italy, 09125 | |
| Firenze, Italy, 50139 | |
| L'Aquila, Italy, 67100 | |
| Milano, Italy, 20162 | |
| Pisa, Italy, 56100 | |
| Sassari, Italy, 07100 | |
| Siena, Italy, 53100 | |
| Udine, Italy, 37100 | |
| Varese, Italy, 21100 | |
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 Italy, decresg@wyeth.com |
More Information
No publications provided
| Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| ClinicalTrials.gov Identifier: | NCT00167947 History of Changes |
| Other Study ID Numbers: | 0468E-101629 |
| Study First Received: | September 9, 2005 |
| Last Updated: | March 13, 2008 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Kidney Transplant |
Additional relevant MeSH terms:
|
Graft vs Host Disease Renal Insufficiency Immune System Diseases Kidney Diseases Urologic Diseases Cyclosporins Cyclosporine Sirolimus Everolimus Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic Antineoplastic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013