Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/3/2014 |
| Start Date: | December 2005 |
| End Date: | June 2014 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Multicenter, Phase 2, Open-Label, Controlled, Extension Study For Stage 1 Subjects Of Study A3921009 To Evaluate The Long-Term Safety And Efficacy Of CP-690,550 Versus Tacrolimus, When Co-Administered With Mycophenolate Mofetil In Renal Allograft Recipients
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune
system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study
A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months
posttransplant. Patients who completed study A3921009 were offered the opportunity to
participate in study A3921021 which will extend the evaluation of safety and efficacy of
CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control
arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects
will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be
discontinued.
system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study
A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months
posttransplant. Patients who completed study A3921009 were offered the opportunity to
participate in study A3921021 which will extend the evaluation of safety and efficacy of
CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control
arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects
will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be
discontinued.
Inclusion Criteria:
- Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with
trial medications (CP-690,550 or tacrolimus)
- Recipient of a first-time kidney transplant
Exclusion Criteria:
- Subject with any untreated condition that may affect drug absorption (eg, gastrectomy
or clinically significant diabetic gastroenteropathy).
- Subjects who are on the waiting list for a second kidney transplant or any non-renal
organ transplants.
We found this trial at
17
sites
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