Kidney TransplantationPhase 2NCT00282230
A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients
A Phase 2 study testing FK778 in people with Kidney Transplantation, run by Astellas Pharma Inc at 23 sites in United States.
Trial summary
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- FK778
- How many people
- 150 participants
- Where
- 23 sitesUnited States
- Study dates
- Nov 2003to Oct 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living donor kidney.
- Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.
Who cannot join
- Patient has received or is receiving an organ transplant other than kidney
- Patient has received a kidney transplant from a cadaveric donor >= 60 years of age.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Study site
Birmingham, Alabama, 35294
Study site
Chicago, Illinois, 60637
Study site
Cincinnati, Ohio, 45267
Study site
Denver, Colorado, 80262
Study site
Detroit, Michigan, 80262
Study site
Durham, North Carolina, 27710
Study site
Harrisburg, Pennsylvania, 17104
Study site
Indianapolis, Indiana, 46202
Study site
Jacksonville, Florida, 32216
Study site
Los Angeles, California, 90057
Study site
Madison, Wisconsin, 53792
Study site
Memphis, Tennessee, 38163
Study site
Miami, Florida, 33136
Study site
Milwaukee, Wisconsin, 53226
Study site
New Brunswick, New Jersey, 89003
Study site
New Orleans, Louisiana, 70121
Study site
New York, New York, 10021
Study site
New York, New York, 10029
Study site
Philadelphia, Pennsylvania, 19107
Study site
Salt Lake City, Utah, 84132
Study site
San Diego, California, 92123
Study site
Washington D.C., District of Columbia, 20010
Study site
Wichita, Kansas, 67214
About this study
Official title: A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Prograf®/FK778 and Prograf®/MMF in De Novo Kidney Transplant Recipients
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
- Conditions
- Kidney Transplantation
- Being tested
- FK778
- Keywords
- Malononitrilamide, immunosuppression, treatment efficacy, treatment outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK778Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.
Secondary outcomes (6)
6 month patient and graft survival rates
time to first biopsy confirmed acute rejection
clinically treated acute rejection episodes
treatment failure (up to 6 months)
renal function (SrCl and CrCl)
quantitation of CMV and polyomavirus viral load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2006 (estimated)
- Study startNov 2003
- Study completionOct 2005
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Investigators
- John Holman, MD, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282230
- Sponsor's protocol ID
- 03-0-165
- Status last verified
- Jun 2012
- First submitted
- 24 Jan 2006
- Last updated
- 7 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Prograf®/FK778 and Prograf®/MMF in De Novo Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00282230
- Acronym / sponsor ID
- 03-0-165
- Conditions
- Kidney Transplantation
- Keywords
- Malononitrilamide, immunosuppression, treatment efficacy, treatment outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Nov 2003
- Study completion
- Oct 2005 (actual)
- First posted
- 26 Jan 2006 (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 evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living donor kidney.
- Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.
Key exclusion criteria (2 listed)
- Patient has received or is receiving an organ transplant other than kidney
- Patient has received a kidney transplant from a cadaveric donor >= 60 years of age.
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 |
|---|---|---|
| FK778 | Drug | – |
Primary outcome
Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.
6 secondary outcomes
6 month patient and graft survival rates
time to first biopsy confirmed acute rejection
clinically treated acute rejection episodes
treatment failure (up to 6 months)
renal function (SrCl and CrCl)
quantitation of CMV and polyomavirus viral load
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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Hypothermic Kidney Machine Perfusion With Omnisol
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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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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 US, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FK778 in people with Kidney Transplantation, run by Astellas Pharma Inc at 23 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: stopped early, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 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 stopped early. Results are not available in the source record.
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?
Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 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 7 Jun 2012.