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

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NCT00518375

Last updated on May 10, 2018
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Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Planned antibody induction therapy

- Multiple organ transplants

- Patients at a high risk of acute rejection

NCT00518375
Pfizer
Completed
Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus

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Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus
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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: Rapamune® (Sirolimus)
  • Drug: Neoral® (Cyclosporine)
  • Drug: Corticosteroids
    Left up to local practice but steroids are typically used perioperatively
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
May 2001
Not Provided

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
Sexes Eligible for Study: All
18 Months and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00518375
0468E1-100154
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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