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Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus

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Wyeth

Status and phase

Completed
Phase 4

Conditions

Kidney Transplantation

Treatments

Drug: Neoral® (Cyclosporine)
Drug: Rapamune® (Sirolimus)
Drug: Corticosteroids

Study type

Interventional

Funder types

Industry

Identifiers

NCT00518375
0468E1-100154

Details and patient eligibility

About

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.

Full description

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months after transplantation were evaluated also.

Sex

All

Ages

18+ months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults more than 18 years of age
  • End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated or living-related mismatched donor
  • Patients with a secondary transplant must have maintained their primary graft for at least 6 months

Exclusion criteria

  • Planned antibody induction therapy
  • Multiple organ transplants
  • Patients at a high risk of acute rejection

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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