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Study Evaluating Sirolimus in Kidney Transplant Recipients

Primary Purpose

Graft vs Host Disease, Kidney Transplantation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
sirolimus
cyclosporine
mycophenolate mofetil
corticosteroids
daclizumab
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft vs Host Disease focused on measuring Kidney, Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Sirolimus + Daclizumab + Mycophenolate + Corticosteroids

Cyclosporine + Mycophenolate + Corticosteroids

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Patient and Graft Survival
Graft survival is measured by graft loss which is defined as removal of the transplant.
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.

Full Information

First Posted
September 12, 2005
Last Updated
April 22, 2010
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00195273
Brief Title
Study Evaluating Sirolimus in Kidney Transplant Recipients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft vs Host Disease, Kidney Transplantation
Keywords
Kidney, Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cyclosporine + Mycophenolate + Corticosteroids
Intervention Type
Drug
Intervention Name(s)
sirolimus
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Intervention Description
1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events
Intervention Type
Drug
Intervention Name(s)
corticosteroids
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
daclizumab
Intervention Description
IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation
Primary Outcome Measure Information:
Title
Mean Creatinine Clearance Rate
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Patients With Acute Rejection
Description
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.
Time Frame
3 and 12 months
Title
Patient and Graft Survival
Description
Graft survival is measured by graft loss which is defined as removal of the transplant.
Time Frame
12 months
Title
Mean Creatinine Clearance Rate - 3 Months
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor, MD
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Norway, Sweden, MedInfoNord@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Oslo
ZIP/Postal Code
N-0027
Country
Norway
City
Gothenburg
ZIP/Postal Code
SE-413 45
Country
Sweden
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden

12. IPD Sharing Statement

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Study Evaluating Sirolimus in Kidney Transplant Recipients

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