Study Evaluating Sirolimus in Kidney Transplant Recipients.

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00167947
• Collaborator: (none)
• Enrollment: 150
• Locations: 14
• Arms: 2
• Duration (Months): 29.9
• Patients Per Site: 10.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Renal function at 12 months assessed by calculated creatinine clearance.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure; Graft vs Host Disease	Drug: Cyclosporine; Drug: Steroids; Drug: Rapamune (Sirolimus)	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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 "

Outcome Measures

Primary Outcome Measures

1. 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. [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Roma	Lazio	Italy	00144
2		Roma	Lazio	Italy	00168
3		Palermo	Sicily	Italy	90127
4		Bari		Italy	70100
5		Bologna		Italy	40138
6		Cagliari		Italy	09125
7		Firenze		Italy	50139
8		L'Aquila		Italy	67100
9		Milano		Italy	20162
10		Pisa		Italy	56100
11		Sassari		Italy	07100
12		Siena		Italy	53100
13		Udine		Italy	37100
14		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, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00167947
• Other Study ID Numbers: 0468E-101629
• First Posted: Sep 14, 2005
• Last Update Posted: Mar 14, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: Kidney; Transplant
• Additional relevant MeSH terms: Renal Insufficiency; Graft vs Host Disease; Cyclosporine; Sirolimus; Cyclosporins

Study Results

No Results Posted as of Mar 14, 2008