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

Kidney Transplantation Clinical Trial

Official title:

A Comparative, Open-label Study to Evaluate Graft Function in de Novo Renal Allograft Recipients Treated With Either a 'Reduced Dose' or a 'Standard Dose' of Cyclosporine in Combination With Sirolimus and Corticosteroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00518375
• Other study ID #: 0468E1-100154
• Status: Completed
• Phase: Phase 4
• Start date: April 2000
• Est. completion date: May 2001

Study information

• Verified date: August 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Rapamune® (Sirolimus)

• Neoral® (Cyclosporine)

• Corticosteroids
Left up to local practice but steroids are typically used perioperatively

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated creatinine clearance to evaluate renal function at 12 months post transplantation		12 months
Secondary	Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation		12 months