Kidney TransplantationPhase 2NCT00556257
Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients
A Phase 2 study testing Cyclosporine and CP-690-,550 in people with Kidney Transplantation, run by Pfizer.
Trial summary
A new immunosuppressive drug based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months in addition to other… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Cyclosporine and CP-690-,550
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient of first time kidney transplant
- Between the ages of 18 and 70 years, inclusive
Who cannot join
- Recipient of any non-kidney transplant
About this study
Official title: A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients
A new immunosuppressive drug based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months in addition to other standard transplant medications such as prednisone.
- Conditions
- Kidney Transplantation
- Being tested
- Cyclosporine, CP-690-,550
- Keywords
- Immunosuppression, JAK3 inhibitor, kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclosporineDrug
Standard of care
CP-690-,550Drug
CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Active comparator | Treatment Arm 1 will also receive standard of care medications. Receives: Drug: Cyclosporine |
| Treatment Arm 2 | Experimental | Treatment Arm 2 will also receive select standard of care medications. Receives: Drug: CP-690-,550 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical biopsy proven acute rejection rate at 6 months
Measured: 6 months
Secondary outcomes (4)
Pharmacokinetics of CP-690,550
Measured: 12 months
Lymphocyte subsets
Measured: 12 months
Posttransplant humoral alloreactivity
Measured: 12 months
Safety and tolerability of CP-690,550
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556257
- Sponsor's protocol ID
- A3921037
- Status last verified
- May 2008
- First submitted
- 8 Nov 2007
- Last updated
- 30 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients
- ClinicalTrials.gov ID
- NCT00556257
- Acronym / sponsor ID
- A3921037
- Conditions
- Kidney Transplantation
- Keywords
- Immunosuppression, JAK3 inhibitor, kidney transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- First posted
- 9 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A new immunosuppressive drug based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months in addition to other standard transplant medications such as prednisone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Active comparator | Drug: CyclosporineTreatment Arm 1 will also receive standard of care medications. |
| Treatment Arm 2 | Experimental | Drug: CP-690-,550Treatment Arm 2 will also receive select standard of care medications. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recipient of first time kidney transplant
- Between the ages of 18 and 70 years, inclusive
Key exclusion criteria (1 listed)
- Recipient of any non-kidney transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclosporineStandard of care | Drug | Treatment Arm 1 |
| CP-690-,550CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12 | Drug | Treatment Arm 2 |
Primary outcome
Clinical biopsy proven acute rejection rate at 6 months
Time frame: 6 months
4 secondary outcomes
Pharmacokinetics of CP-690,550
Time frame: 12 months
Lymphocyte subsets
Time frame: 12 months
Posttransplant humoral alloreactivity
Time frame: 12 months
Safety and tolerability of CP-690,550
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclosporine and CP-690-,550 in people with Kidney Transplantation, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 May 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical biopsy proven acute rejection rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2008.