Phase 1 Completed N=24 Randomized Double-blind Basic Science

A Study Of CP-690,550 In Stable Kidney Transplant Patients

Source: ClinicalTrials.gov NCT01710033 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Dec 2012

Primary outcomePrimary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550 — 183; 754; 1200 nanogram*hour per milliliter (ng*hr/mL)

Summary

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550	183; 754; 1200	—
PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550	319; 1300; 1560	—
PRIMARY Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550	273; 1090; 1420	—
PRIMARY Maximum Observed Plasma Concentration (Cmax) For CP-690,550	41.0; 140; 325	—
PRIMARY Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550	52.2; 220; 351	—
PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550	0.75; 1.50; 0.50	—
PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550	0.75; 0.50; 0.50	—
PRIMARY Accumulation Ratio (Rac) For CP-690,550	1.48; 1.39; 1.22	—
PRIMARY Plasma Decay Half-Life (t1/2) For CP-690,550	3.36; NA; 2.94	—
PRIMARY Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550	5.18; 5.15; 3.71	—
PRIMARY Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline	2.73; 2.18; 1.84; 2.43	—
PRIMARY Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8	3.25; 2.11; 1.29; 2.56	—
PRIMARY Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15	3.15; 2.36; 1.48; 2.74	—
PRIMARY Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29	2.61; 2.68; 4.30; 3.24	—
PRIMARY Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57	2.60; 2.89; 1.75; 2.67	—
PRIMARY Cyclosporine (CsA) Plasma Trough Concentration at Baseline	249.50; 81.00; 173.00	—
PRIMARY Cyclosporine (CsA) Plasma Trough Concentration at Day 8	137.00; 77.25; 134.00	—
PRIMARY Cyclosporine (CsA) Plasma Trough Concentration at Day 15	207.00; 86.60; 160.33	—
PRIMARY Cyclosporine (CsA) Plasma Trough Concentration at Day 29	226.00; 96.00; 125.00	—
PRIMARY Cyclosporine (CsA) Plasma Trough Concentration at Day 57	292.00; 91.20; 152.00	—
PRIMARY Tacrolimus (TAC) Plasma Trough Concentration at Baseline	6.75; 7.17	—
PRIMARY Tacrolimus (TAC) Plasma Trough Concentration at Day 8	7.50; 8.00	—
PRIMARY Tacrolimus (TAC) Plasma Trough Concentration at Day 15	8.00; 6.67	—
PRIMARY Tacrolimus (TAC) Plasma Trough Concentration at Day 29	7.00; 12.67	—
PRIMARY Tacrolimus (TAC) Plasma Trough Concentration at Day 57	5.00; 6.33	—

Eligibility Criteria

Inclusion Criteria

Medically stable kidney transplant patients 6 or more months after transplantation.
Subjects must be on mycophenolate mofetil 1-2 gm daily
In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.

Exclusion Criteria

Any rejection episodes in the preceding 3 months.
Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01710033). 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.