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Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Cedars-Sinai Medical Center
Los Angeles, California, 90048 United States
Contact
1-800-718-1021
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
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who successfully completed Study A3921030

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

- Subjects who are on the waiting list for a second kidney transplant or any non-renal
organ transplants

NCT00658359
Pfizer
Completed
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients

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[email protected]

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Similar Trials

Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
A Phase 2, Multicenter, Open-label, Active Comparator-controlled, Extension Trial To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 In Renal Allograft Recipients
This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: Cyclosporine
    Standard of care
  • Drug: CP-690,550
    CP-690,550 tablets dosed BID Months 12-72
  • Active Comparator: Treatment Arm 1
    Treatment Arm 1 will also receive standard of care medications
    Intervention: Drug: Cyclosporine
  • Experimental: Treatment Arm 2
    Treatment Arm 2 will also receive standard of care medications
    Intervention: Drug: CP-690,550
  • Experimental: Treatment Arm 3
    Treatment Arm 3 will also receive standard of care medications
    Intervention: Drug: CP-690,550
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
June 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who successfully completed Study A3921030

Exclusion Criteria:

  • Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Portugal,   Spain,   United States
 
 
NCT00658359
A3921050
2008-002345-23 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2015

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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