Study Evaluating Sirolimus in Kidney Transplant Recipients

Kidney Transplantation Clinical Trial

Official title:

A Randomized Open-Label Study Comparing the Efficacy and Safety of Sirolimus Combined With Daclizumab, Mycophenolate and Corticosteroids vs Cyclosporine, Mycophenolate and Corticosteroids in Renal Allograft Recipients Receiving Kidneys From Older Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00195273
• Other study ID #: 0468H-101466
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 22, 2010
• Start date: November 2004
• Est. completion date: July 2008

Study information

• Verified date: April 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Kidney transplantation

• Donor must be at least 60 years old.

Exclusion Criteria:

• Current systemic infection

• Unstable angina or treatment for serious arrhythmia.

• Cancer within the previous 5 years.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Kidney Transplantation

Intervention

Drug:
• sirolimus
15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12
• cyclosporine
Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12
• mycophenolate mofetil
1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events
• corticosteroids
As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day
• daclizumab
IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Creatinine Clearance Rate	Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.	12 months	No
Secondary	Number of Patients With Acute Rejection	The diagnosis of acute rejection was made via kidney biopsy (Banff criteria). The Banff criteria are standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Biopsy was performed before initiation of anti-rejection therapy, or at least within 24 hours of the start of therapy.	3 and 12 months	No
Secondary	Patient and Graft Survival	Graft survival is measured by graft loss which is defined as removal of the transplant.	12 months	No
Secondary	Mean Creatinine Clearance Rate - 3 Months	Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.	3 months	No