Graft RejectionPhase 4CRAFNCT00510913
A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
A Phase 4 study testing tacrolimus in people with Graft Rejection and Kidney Transplantation, run by Astellas Pharma Inc at 18 sites in United States.
Trial summary
A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Graft Rejection, Kidney Transplantation
- What is being tested?
- tacrolimus
- How many people
- 450 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 1999to Sep 2000
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has been on cyclosporine-based immunosuppression regimen since the transplant
- Patient has at least one pre-defined risk factor for chronic allograft failure
Who cannot join
- Patient is dialysis dependent
- Patient is recipient of a solid organ transplant other than the kidney
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Albany, New York
Study site
Augusta, Georgia
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Denver, Colorado
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Minneapolis, Minnesota
Study site
Nashville, Tennessee
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
San Francisco, California
About this study
Official title: Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure
Read the detailed description
A two arm study (1 Active, 1 Active control) to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine-based to tacrolimus-based immunosuppression to patients who remain on cyclosporine-based therapy
- Conditions
- Graft Rejection, Kidney Transplantation
- Being tested
- tacrolimus
- Keywords
- Treatment efficacy, Transplantation rejection, Kidney transplantation, Cyclosporine, tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called Prograf®, FK506
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Survival
Measured: 5 years
Secondary outcomes (1)
Patient survival, Graft Loss
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startFeb 1999
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft RejectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Holman, MD, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510913
- Sponsor's protocol ID
- 20-98-002
- Acronym
- CRAF
- Status last verified
- Jul 2007
- First submitted
- 31 Jul 2007
- Last updated
- 2 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
- ClinicalTrials.gov ID
- NCT00510913
- Acronym / sponsor ID
- CRAF / 20-98-002
- Conditions
- Graft Rejection, Kidney Transplantation
- Keywords
- Treatment efficacy, Transplantation rejection, Kidney transplantation, Cyclosporine, tacrolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 1999
- Study completion
- Sep 2000 (actual)
- First posted
- 2 Aug 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 study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure
Detailed description
A two arm study (1 Active, 1 Active control) to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine-based to tacrolimus-based immunosuppression to patients who remain on cyclosporine-based therapy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has been on cyclosporine-based immunosuppression regimen since the transplant
- Patient has at least one pre-defined risk factor for chronic allograft failure
Key exclusion criteria (2 listed)
- Patient is dialysis dependent
- Patient is recipient of a solid organ transplant other than the kidney
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 |
|---|---|---|
| tacrolimusAlso: Prograf®, FK506 | Drug | – |
Primary outcome
Graft Survival
Time frame: 5 years
1 secondary outcome
Patient survival, Graft Loss
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2007.
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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.
John Holman, MD study director
Astellas Pharma Inc
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tacrolimus in people with Graft Rejection and Kidney Transplantation, run by Astellas Pharma Inc at 18 sites in United States.
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 2 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: finished, as of the sponsor's last update on 2 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Graft Survival (time frame: 5 years). 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 2 Aug 2007.