Kidney TransplantationPhase 3NCT00717678
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Kidney Transplant Recipients
A Phase 3 study testing Prograf-XL, Prograf and MMF in people with Kidney Transplantation and Transplantation Immunology, run by Astellas Pharma Inc at 5 sites in Taiwan.
Trial summary
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Kidney Transplantation, Transplantation Immunology, Host vs Graft Reaction
- What is being tested?
- Prograf-XL, Prograf and MMF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 5 sitesTaiwan
- Study dates
- Dec 2007to Apr 2010
- Phase
- Phase 3
- 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 fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
- Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant
- Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization
Who cannot join
- Patient has previously received or is receiving an organ transplant other than a kidney
- Patient has received a kidney transplant from a non-heart beating donor
- Patient has received an ABO incompatible donor kidney
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- Patient has significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
Show all 13Show fewer
- Patient has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
- Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
- Patient is receiving everolimus or enteric coated mycophenolic acid at any time during the study
- Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids
- Patient is pregnant or lactating
- Patient is unlikely to comply with the visits scheduled in the protocol
- Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Study site
Taichung, 407
Study site
Tainan, 704
Study site
Taipei, 100
Study site
Taipei, 112
Study site
Taoyuan, 333
About this study
Official title: A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF in de Novo Kidney Transplant Recipients
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.
- Being tested
- Prograf-XL, Prograf, MMF
- Keywords
- Immunosuppressant, Combination drug therapy, Graft loss, Randomized controlled trial, Open level method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prograf-XLDrug
Also called tacrolimus extended release, FK506XL, MR4
oral
PrografDrug
Also called tacrolimus, FK506
oral
MMFDrug
Also called Mycophenolate Mofetil
oral
| Study group | Role | What they receive |
|---|---|---|
| Prograf-XL + MMF | Experimental | Not described Receives: Drug: Prograf-XL; Drug: MMF |
| Prograf + MMF | Active comparator | Not described Receives: Drug: Prograf; Drug: MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient and graft survival rates at 6 month post-transplant
Measured: 6 months
Secondary outcomes (3)
Efficacy failure at 6-month posttransplant.
Measured: 6 months
Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months
Measured: 6 months and 12 months
1 year patient and graft survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2010
- Study completionApr 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717678
- Sponsor's protocol ID
- PRGXLKTx-0701-TW
- Status last verified
- Dec 2015
- First submitted
- 16 Jul 2008
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF in de Novo Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00717678
- Acronym / sponsor ID
- PRGXLKTx-0701-TW
- Keywords
- Immunosuppressant, Combination drug therapy, Graft loss, Randomized controlled trial, Open level method
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- Dec 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Jul 2008 (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.
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prograf-XL + MMF | Experimental | Drug: Prograf-XL, Drug: MMF |
| Prograf + MMF | Active comparator | Drug: Prograf, Drug: MMF |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
- Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant
- Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization
Key exclusion criteria (13 listed)
- Patient has previously received or is receiving an organ transplant other than a kidney
- Patient has received a kidney transplant from a non-heart beating donor
- Patient has received an ABO incompatible donor kidney
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
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 |
|---|---|---|
| Prograf-XLAlso: tacrolimus extended release, FK506XL, MR4oral | Drug | Prograf-XL + MMF |
| PrografAlso: tacrolimus, FK506oral | Drug | Prograf + MMF |
| MMFAlso: Mycophenolate Mofetiloral | Drug | Prograf + MMF, Prograf-XL + MMF |
Primary outcome
The patient and graft survival rates at 6 month post-transplant
Time frame: 6 months
3 secondary outcomes
Efficacy failure at 6-month posttransplant.
Time frame: 6 months
Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months
Time frame: 6 months and 12 months
1 year patient and graft survival
Time frame: 1 year
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 17 Dec 2015.
- Individual participant dataSharing planned: Undecided
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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.
Central Contact study chair
Astellas Pharma Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prograf-XL, Prograf and MMF in people with Kidney Transplantation and Transplantation Immunology, run by Astellas Pharma Inc at 5 sites in Taiwan.
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 4 inclusion and 13 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 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 patient and graft survival rates at 6 month post-transplant (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 17 Dec 2015.