Phase 2
N=331
Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00483756 ↗Enrolled (actual)
331
Serious AEs
66.8%
Results posted
Mar 2013
Primary outcome: Primary: Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant — 9; 11; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclosporine (Drug); CP-690,550 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant |
9; 11; 7 | — |
| PRIMARY Glomerular Filtration Rate (GFR) at Month 12 |
54.14; 65.05; 65.37 | — |
| SECONDARY Glomerular Filtration Rate (GFR) at Month 6 |
57.29; 67.54; 73.93 | — |
| SECONDARY Number of Participants With Progression of Chronic Allograft Lesions at Month 12 |
29; 18; 19 | — |
| SECONDARY Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant |
9; 11; 7 | — |
| SECONDARY Number of Participants With Treated Clinical Acute Rejection |
21; 23; 18; 25; 26; 18 | — |
| SECONDARY Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4) |
29; 22; 20; 30; 24; 23 | — |
| SECONDARY Number of Participants With Graft Loss |
1; 1; 3; 1; 1; 3 | — |
| SECONDARY Number of Participants With Efficacy Failure |
21; 19; 14; 22; 20; 16 | — |
| SECONDARY Number of Participants Who Died |
2; 2; 0; 2; 2; 0 | — |
| SECONDARY Lymphocyte Subset |
1555.0; 1256.7; 1327.2; 1273.2; 894.20; 1007.1 | — |
| SECONDARY Population Pharmacokinetics (PK) |
— | — |
| SECONDARY Glomerular Filtration Rate (GFR) by The Nankivell Equation |
65.85; 71.53; 73.66; 65.80; 73.58; 72.91 | — |
| SECONDARY Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation |
67.23; 71.12; 73.55; 68.08; 74.41; 74.16 | — |
| SECONDARY Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation |
52.89; 59.93; 63.61; 53.55; 62.20; 62.81 | — |
| SECONDARY Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation |
55.29; 61.49; 64.81; 54.36; 62.45; 62.27 | — |
| SECONDARY Number of Participants With Clinically Significant Infections |
61; 88; 83 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) |
52.89; 51.43; 49.56; 44.77; 42.46; 42.39 | — |
| SECONDARY End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL) |
0.76; 0.70; 0.64; 0.19; 0.16; 0.18 | — |
| SECONDARY Severity of Dyspepsia Assessment (SODA) |
— | — |
Summary
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 this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.
Eligibility Criteria
Inclusion Criteria
- Recipient of a first-time kidney transplant
- Between the ages of 18 and 70 years, inclusive
Exclusion Criteria
- Recipient of any non-kidney transplant
Data sourced from ClinicalTrials.gov (NCT00483756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.