Renal TransplantationPhase 4OPTIMANCT00297765
Optimizing Prograf® Therapy in Renal Transplant Patients
A Phase 4 study testing Tacrolimus, Prograf® in people with Renal Transplantation, run by Astellas Pharma Inc at 42 sites in United States.
Trial summary
A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- Tacrolimus, Prograf®
- How many people
- 323 participants
- Where
- 42 sitesUnited States
- Study dates
- Jan 2003to Mar 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient was 18 years of age at the time of transplant.
- Patient is at least 6 months post-transplant.
Who cannot join
- Patient is the recipient of a solid organ transplant other than the kidney.
- Patient is a known carrier of any of the HIV viruses.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Atlanta, Georgia, 30309
Study site
Augusta, Georgia, 30912
Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02114
Study site
Buffalo, New York, 14203
Study site
Charleston, South Carolina, 29425
Study site
Dallas, Texas, 75204
Study site
Denver, Colorado, 80262
Study site
Galveston, Texas, 77555
Study site
Greenville, North Carolina, 27834
Study site
Hershey, Pennsylvania, 17033
Study site
Honolulu, Hawaii, 96817
Study site
Indianapolis, Indiana, 46202
Study site
Little Rock, Arkansas, 72205
Study site
Livingston, New Jersey, 07039
Study site
Long Island City, New York, 11794
Study site
Los Angeles, California, 90057
Study site
Mineola, New York, 11501
Study site
Minneapolis, Minnesota, 55455
Study site
Nashville, Tennessee, 37232
Study site
New York, New York, 10016
Study site
New York, New York, 10021
Study site
New York, New York, 10032
Study site
Omaha, Nebraska, 68198
Study site
Palo Alto, California, 94304
Study site
Peoria, Illinois, 61603
Study site
Philadelphia, Pennsylvania, 19102
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19107
Study site
Philadelphia, Pennsylvania, 19141
Study site
Portland, Maine, 04102
Study site
Richmond, Virginia, 23298
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78284
Study site
San Diego, California, 92123
Study site
San Francisco, California, 94115
Study site
Seattle, Washington, 98104
Study site
Shreveport, Louisiana, 71103
Study site
Spokane, Washington, 99208
Study site
Washington D.C., District of Columbia, 20037
Study site
West Orange, New Jersey, 07052
About this study
Official title: OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)
A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.
Read the detailed description
A 3 arm study (2 Active, 1 Active Control) to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients
- Conditions
- Renal Transplantation
- Being tested
- Tacrolimus, Prograf®
- Keywords
- Renal Transplantation, Therapeutics, Treatment Outcome, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus, Prograf®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of conversion from cyclosporine to Prograf-based therapy on renal function
Measured: 12 months
Secondary outcomes (1)
Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startJan 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
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
- NCT00297765
- Sponsor's protocol ID
- 20-02-002
- Acronym
- OPTIMA
- Status last verified
- Dec 2007
- First submitted
- 28 Feb 2006
- Last updated
- 26 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)
- ClinicalTrials.gov ID
- NCT00297765
- Acronym / sponsor ID
- OPTIMA / 20-02-002
- Conditions
- Renal Transplantation
- Keywords
- Renal Transplantation, Therapeutics, Treatment Outcome, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Jan 2003
- Study completion
- Mar 2006 (actual)
- First posted
- 1 Mar 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 determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.
Detailed description
A 3 arm study (2 Active, 1 Active Control) to determine the optimal dose and blood level of Prograf® in long-term maintenance of 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 was 18 years of age at the time of transplant.
- Patient is at least 6 months post-transplant.
Key exclusion criteria (2 listed)
- Patient is the recipient of a solid organ transplant other than the kidney.
- Patient is a known carrier of any of the HIV viruses.
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 |
|---|---|---|
| Tacrolimus, Prograf® | Drug | – |
Primary outcome
The effect of conversion from cyclosporine to Prograf-based therapy on renal function
Time frame: 12 months
1 secondary outcome
Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival
Time frame: 24 months
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 26 Aug 2008.
Related trials for Renal Transplantation
RecruitingPhase 1
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
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Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Active, not recruitingPhase 2
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
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.
42 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, Prograf® in people with Renal Transplantation, run by Astellas Pharma Inc at 42 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 26 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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?
The effect of conversion from cyclosporine to Prograf-based therapy on renal function (time frame: 12 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 26 Aug 2008.