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

November 26, 2012 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35249-6860
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294-6862
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90057
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Pfizer Investigational Site
    • Missouri
      • St Louis, Missouri, United States, 63110-1093
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63110-1092
        • Pfizer Investigational Site
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo tables twice daily (BID) for 28 days
Experimental: CP-690,550 15 mg BID
Drug: CP-690,550 15 mg BID
CP-690,550 15 mg BID for 28 days
Experimental: CP-690,550 30 mg BID
Drug: CP-690,550 30 mg BID
CP-690,550 30 mg BID for 28 days
Experimental: CP-690,550 5 mg BID
Drug: CP-690,550 5 mg BID
CP-690,550 5 mg BID for 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
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.
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
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.
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29
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
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
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
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
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
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
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
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
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).
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29
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.
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
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.
0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
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.
Screening, 0 hour (pre-dose) on Day 1
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.
0 hour (pre-dose) on Day 8
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.
0 hour (pre-dose) on Day 15
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.
0 hour (pre-dose) on Day 29
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.
0 hour (pre-dose) on Day 57
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.
Screening, 0 hour (pre-dose) on Day 1
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.
0 hour (pre-dose) on Day 8
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.
0 hour (pre-dose) on Day 15
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.
0 hour (pre-dose) on Day 29
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.
0 hour (pre-dose) on Day 57
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.
Screening, 0 hour (pre-dose) on Day 1
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.
0 hour (pre-dose) on Day 8
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.
0 hour (pre-dose) on Day 15
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.
0 hour (pre-dose) on Day 29
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.
0 hour (pre-dose) on Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3921007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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