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Study Evaluating Sirolimus in Kidney Transplant Recipients.

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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00167947
Enrollment
150
Registered
2005-09-14
Start date
2005-01-31
Completion date
2007-07-31
Last updated
2008-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft vs Host Disease, Kidney Failure

Keywords

Kidney, Transplant

Brief summary

Renal function at 12 months assessed by calculated creatinine clearance.

Interventions

DRUGCyclosporine

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

DRUGSteroids

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

DRUGRapamune (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

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026