Phase 2
Completed N=61
A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
Source: ClinicalTrials.gov NCT00106639 ↗Enrolled (actual)
61
Serious AEs
39.3%
Results posted
Mar 2013
Primary outcomePrimary: Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6 — 1; 4; 1 participants
Summary
This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6 |
1; 4; 1 | — |
| PRIMARY Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6 |
76.53; 71.50; 78.70 | — |
| SECONDARY Number of Participants With Treatment Failure |
1; 7; 2; 3; 9; 3 | — |
| SECONDARY Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3 |
0; 4; 1 | — |
| SECONDARY Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN) |
0; 0; 0; 0; 2; 0 | — |
| SECONDARY Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR) |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN) |
0; 0; 0; 0; 2; 0 | — |
| SECONDARY Number of Participants With Efficacy Failure |
0; 4; 1; 1; 4; 1 | — |
| SECONDARY Number of Participants With Graft Loss |
0; 0; 0 | — |
| SECONDARY Number of Participants Who Died |
0; 0; 0 | — |
| SECONDARY Number of Participants With Rejection |
1; 4; 1; 2; 4; 1 | — |
| SECONDARY Population Pharmacokinetics (PK) |
— | — |
| SECONDARY Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets |
113.95; 114.05; 160.37; 449.84; 471.79; 401.68 | — |
| SECONDARY Reticulocyte Count |
81.75; 68.50; 75.67; 93.06; 109.47; 81.61 | — |
| SECONDARY Trough Levels of Tacrolimus (TAC) |
11.17; 9.11; 8.82; 8.33 | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) |
49.89; 52.15; 50.46; 54.79; 55.06; 57.54 | — |
| SECONDARY End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) |
0.60; 0.78; 0.67; 0.26; 0.30; 0.22 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire (HCRUQ) |
3.33; 4.31; 4.47; 4.20; 7.29; 8.70 | — |
| SECONDARY Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question |
7; 6; 6; 2; 0; 1 | — |
| SECONDARY Glomerular Filtration Rate (GFR) by Cockcroft-Gault |
73.24; 78.37; 76.14; 80.73; 81.83; 79.90 | — |
| SECONDARY Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation |
60.67; 57.97; 56.70; 66.82; 62.70; 62.55 | — |
| SECONDARY Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr) |
0.87; 0.75; 0.75; 0.91; 0.79; 0.78 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
20; 18; 21; 8; 10; 6 | — |
| SECONDARY Number of Participants With First Clinically Significant Infection |
2; 7; 3; 6; 11; 5 | — |
| SECONDARY Number of Participants With New Onset Diabetes Mellitus (NODM) |
0; 0; 2; 1; 0; 2 | — |
| SECONDARY Fasting Serum Glucose Levels |
114.50; 102.68; 90.29; 131.58; 95.58; 99.85 | — |
| SECONDARY Number of Participants With Hypercholesterolemia |
1; 1; 0; 5; 5; 1 | — |
| SECONDARY Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels |
168.78; 159.79; 166.86; 217.21; 208.05; 184.95 | — |
| SECONDARY Number of Participants With Hypertriglyceridemia |
4; 7; 5; 7; 2; 6 | — |
| SECONDARY Supine Systolic and Diastolic Blood Pressure (BP) |
77.10; 75.25; 76.52; 79.05; 80.20; 78.50 | — |
| SECONDARY Number of Participants With Drug Usage |
6; 9; 9; 3; 4; 4 | — |
| SECONDARY Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load |
2.65; 0.26; 3.21; 4.22; 0.58; 3.60 | — |
| SECONDARY BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load |
0.00; 0.05; 0.05; 0.00; 5.33; 0.00 | — |
| SECONDARY Number of Participants With Cytomegalovirus (CMV) Disease |
0; 4; 0; 2; 4; 0 | — |
| SECONDARY Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil |
12.75; 11.09; 11.82; 12.76; 13.81; 10.24 | — |
| SECONDARY Absolute Platelet Levels |
186.75; 204.85; 195.19; 330.17; 367.84; 301.28 | — |
| SECONDARY Hemoglobin Level |
11.04; 10.65; 11.84; 11.83; 11.68; 11.93 | — |
| SECONDARY Hematocrit Level |
34.75; 33.30; 36.86; 37.78; 37.16; 37.11 | — |
| SECONDARY Alanine Aminotransferase (ALT) Level |
24.84; 18.45; 18.33; 39.05; 70.63; 31.50 | — |
| SECONDARY Electrocardiogram (ECG) Parameters |
147.60; 141.82; 151.53; 156.37; 156.00; 150.17 | — |
| SECONDARY Number of Participants With Discontinuation |
0; 1; 0; 1; 1; 0 | — |
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 (NCT00106639). 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. Informational only — not medical advice.