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Study Evaluating Sirolimus in Kidney Transplant Recipients.

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Kidney Failure
Graft vs Host Disease

Treatments

Drug: Steroids
Drug: Rapamune (Sirolimus)
Drug: Cyclosporine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00167947
0468E-101629

Details and patient eligibility

About

Renal function at 12 months assessed by calculated creatinine clearance.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

A
Active Comparator group
Treatment:
Drug: Rapamune (Sirolimus)
Drug: Steroids
Drug: Cyclosporine
B
Experimental group
Treatment:
Drug: Rapamune (Sirolimus)
Drug: Steroids
Drug: Cyclosporine

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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