We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00658359
First Posted: April 15, 2008
Last Update Posted: August 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
April 9, 2008
April 15, 2008
August 20, 2015
August 2008
March 2015   (Final data collection date for primary outcome measure)
  • Long-term efficacy of CP-690,550 [ Time Frame: 6 years ]
  • Long-term safety and tolerability of CP-690,550 [ Time Frame: 6 years ]
  • Long-term safety and tolerability of CP-690,550 [ Time Frame: 3 years ]
  • Long-term efficacy of CP-690,550 [ Time Frame: 3 years ]
Complete list of historical versions of study NCT00658359 on ClinicalTrials.gov Archive Site
  • Additional measures of efficacy of CP-690,550 [ Time Frame: 6 years ]
  • Effects of CP-690,550 on health outcome assessments [ Time Frame: 3 years ]
  • Relationship of CP-690,550 concentration and safety/efficacy endpoints [ Time Frame: 6 years ]
  • Additional measures of efficacy of CP-690,550 [ Time Frame: 3 years ]
  • Effects of CP-690,550 on health outcome assessments [ Time Frame: 3 years ]
  • Relationship of CP-690,550 concentration and safety/efficacy endpoints [ Time Frame: 3 years ]
Not Provided
Not Provided
 
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