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Completed

NCT Number: NCT01710033

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

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.

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Key information

Conditions

Kidney Transplant

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo tables twice daily (BID) for 28 days

CP-690,550 5 mg BID

Drug

CP-690,550 5 mg BID for 28 days

CP-690,550 15 mg BID

Drug

CP-690,550 15 mg BID for 28 days

CP-690,550 30 mg BID

Drug

CP-690,550 30 mg BID for 28 days

Primary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550

    Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550

    Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.

  3. Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550

    Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29

    Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.

  4. Maximum Observed Plasma Concentration (Cmax) For CP-690,550

    Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

  5. Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550

    Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550

    Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

  7. Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550

    Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

  8. Accumulation Ratio (Rac) For CP-690,550

    Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29

    Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).

  9. Plasma Decay Half-Life (t1/2) For CP-690,550

    Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  10. Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550

    Time frame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.

  11. Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline

    Time frame: Screening, 0 hour (pre-dose) on Day 1

    Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.

  12. Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8

    Time frame: 0 hour (pre-dose) on Day 8

    Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.

  13. Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15

    Time frame: 0 hour (pre-dose) on Day 15

    Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.

  14. Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29

    Time frame: 0 hour (pre-dose) on Day 29

    Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.

  15. Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57

    Time frame: 0 hour (pre-dose) on Day 57

    Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.

  16. Cyclosporine (CsA) Plasma Trough Concentration at Baseline

    Time frame: Screening, 0 hour (pre-dose) on Day 1

    The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

  17. Cyclosporine (CsA) Plasma Trough Concentration at Day 8

    Time frame: 0 hour (pre-dose) on Day 8

    CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

  18. Cyclosporine (CsA) Plasma Trough Concentration at Day 15

    Time frame: 0 hour (pre-dose) on Day 15

    CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

  19. Cyclosporine (CsA) Plasma Trough Concentration at Day 29

    Time frame: 0 hour (pre-dose) on Day 29

    CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

  20. Cyclosporine (CsA) Plasma Trough Concentration at Day 57

    Time frame: 0 hour (pre-dose) on Day 57

    CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.

  21. Tacrolimus (TAC) Plasma Trough Concentration at Baseline

    Time frame: Screening, 0 hour (pre-dose) on Day 1

    The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

  22. Tacrolimus (TAC) Plasma Trough Concentration at Day 8

    Time frame: 0 hour (pre-dose) on Day 8

    TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

  23. Tacrolimus (TAC) Plasma Trough Concentration at Day 15

    Time frame: 0 hour (pre-dose) on Day 15

    TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

  24. Tacrolimus (TAC) Plasma Trough Concentration at Day 29

    Time frame: 0 hour (pre-dose) on Day 29

    TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

  25. Tacrolimus (TAC) Plasma Trough Concentration at Day 57

    Time frame: 0 hour (pre-dose) on Day 57

    TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase 1, Placebo-controlled, Randomized, Sequential, Parallel-group, Dose Escalation Study to Evaluate 28-day Multiple Dose Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-690,550 in Stable Renal Allograft Recipients

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 18, 2012
Registry last updated
Dec 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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