NCT00106639

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

March 12, 2013

Completed
Last Updated

March 12, 2013

Status Verified

February 1, 2013

Enrollment Period

1.2 years

First QC Date

March 28, 2005

Results QC Date

December 6, 2012

Last Update Submit

February 6, 2013

Conditions

Kidney Transplantation

Keywords

tofacitinibCP-690550kidney transplant

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6

    BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.

    Baseline up to Month 6

  • Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6

    GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25\*body weight) minus (0.5\*serum urea) minus (100 per square height) plus (35 for male/25 for female). A normal GFR is \>90 milliliter/minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.

    Month 6

Secondary Outcomes (39)

  • Number of Participants With Treatment Failure

    Month 3, 6

  • Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3

    Baseline up to Month 3

  • Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)

    Month 3, 6

  • Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)

    Month 3, 6

  • Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)

    Month 3, 6

  • +34 more secondary outcomes

Study Arms (3)

CP-690,550 15 mg BID

EXPERIMENTAL
Drug: CP-690,550

CP-690,550 30 mg BID

EXPERIMENTAL
Drug: CP-690,550

tacrolimus

ACTIVE COMPARATOR
Drug: tacrolimus

Interventions

CP-690,550DRUG

15 mg twice daily

CP-690,550 15 mg BID
tacrolimusDRUG

dose adjusted according to level

tacrolimus

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipient of a first-time kidney transplant
  • Between the ages of 18 and 70 years, inclusive

You may not qualify if:

  • Recipient of any non-kidney transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Pfizer Investigational Site

Los Angeles, California, 90057, United States

Location

Pfizer Investigational Site

Los Angeles, California, 92356, United States

Location

Pfizer Investigational Site

Palo Alto, California, 94304, United States

Location

Pfizer Investigational Site

San Diego, California, 92123, United States

Location

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

San Francisco, California, 94143-0780, United States

Location

Pfizer Investigational Site

Stanford, California, 94305, United States

Location

Pfizer Investigational Site

Denver, Colorado, 80262, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60611, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70112, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110-1092, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Livingston, New Jersey, 07039, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

New York, New York, 10029, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97210, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75204, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75246, United States

Location

Pfizer Investigational Site

Richmond, Virginia, 23298, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Busque S, Leventhal J, Brennan DC, Steinberg S, Klintmalm G, Shah T, Mulgaonkar S, Bromberg JS, Vincenti F, Hariharan S, Slakey D, Peddi VR, Fisher RA, Lawendy N, Wang C, Chan G. Calcineurin-inhibitor-free immunosuppression based on the JAK inhibitor CP-690,550: a pilot study in de novo kidney allograft recipients. Am J Transplant. 2009 Aug;9(8):1936-45. doi: 10.1111/j.1600-6143.2009.02720.x.

    PMID: 19660021DERIVED

Related Links

MeSH Terms

Interventions

tofacitinibTacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Limitations and Caveats

Results for first BPAR, BPCAN, treatment and efficacy failure, rejection, clinically significant infections, NODM and discontinuation reported as number and not percentage as planned. Stage 2 of study was not conducted due to administrative reasons.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2005

First Posted

March 29, 2005

Study Start

May 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

March 12, 2013

Results First Posted

March 12, 2013

Record last verified: 2013-02

Locations

US(20)