Kidney TransplantationPhase 4NCT00087581
Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation
A Phase 4 study testing Mycophenolate mofetil, Cyclosporine and Tacrolimus in people with Kidney Transplantation, run by Hoffmann-La Roche at 57 sites in United States.
Trial summary
This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Mycophenolate mofetil, Cyclosporine and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 57 sitesUnited States
- Study dates
- Jun 2004to Sep 2007
- 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 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males or females 13-75 years of age
- Single organ recipient (kidney only) from living (related or unrelated) or cadaveric heart-beating donors
- Receiving first or second kidney transplant
Who cannot join
- Immunosuppressive therapy (except for 48 hours prior to transplantation and corticosteroid treatment) within previous 28 days for a first transplant and 3 months for a second transplant
- History of malignancy in last 5 years (except successfully treated localized non-melanoma skin cancer)
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Study site
Ann Arbor, Michigan, 48109-0362
Study site
Augusta, Georgia, 30912
Study site
Bakersfield, California, 93309
Study site
Baltimore, Maryland, 21287-8611
Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02111
Study site
Boston, Massachusetts, 02215
Study site
Buffalo, New York, 14203
Study site
Burlington, Massachusetts, 01805
Study site
Burlington, Vermont, 05401
Study site
Chapel Hill, North Carolina, 27599
Study site
Chicago, Illinois, 60637
Study site
Cleveland, Ohio, 44106
Study site
Dallas, Texas, 75246
Study site
Denver, Colorado, 80262
Study site
Detroit, Michigan, 48202-2689
Study site
Falls Church, Virginia, 22042-3300
Study site
Fargo, North Dakota, 58122
Study site
Gainesville, Florida, 32610-0224
Study site
Hackensack, New Jersey, 07601
Study site
Harrisburg, Pennsylvania, 17101
Study site
Hawthorne, New York, 10532
Study site
Hershey, Pennsylvania, 17033
Study site
Indianapolis, Indiana, 46202-5124
Study site
Jacksonville, Florida, 32216
Study site
Lexington, Kentucky, 40536-0293
Study site
Little Rock, Arkansas, 72205
Study site
Livingston, New Jersey, 07039
Study site
Los Angeles, California, 90048
Study site
Los Angeles, California, 90057
Study site
Madison, Wisconsin, 53792
Study site
Miami, Florida, 33101
Study site
New Orleans, Louisiana, 70121
Study site
New York, New York, 10021
Study site
New York, New York, 10029
Study site
New York, New York, 10032
Study site
Norfolk, Virginia, 23502
Study site
Orlando, Florida, 32804
Study site
Philadelphia, Pennsylvania, 19102-1192
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19140
Study site
Pittsburgh, Pennsylvania, 15212
Study site
Portland, Oregon, 97210
Study site
Providence, Rhode Island, 02903
Study site
Rochester, Minnesota, 55905
Study site
Rochester, New York, 14642-8410
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78284
Study site
San Francisco, California, 94143-0116
Study site
Seattle, Washington, 98104
Study site
Shreveport, Louisiana, 71130
Study site
Springfield, Massachusetts, 01107
Study site
Tampa, Florida, 33606
Study site
The Bronx, New York, 10467
Study site
Wichita, Kansas, 67214
Study site
Winston-Salem, North Carolina, 27157
Study site
Worcester, Massachusetts, 01655
About this study
Official title: An Open-Label, Prospective, Randomized, Controlled, Multi-Center Study Assessing Fixed Dose Versus Concentration Controlled Cellcept® Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors
This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Participants will be randomized to one of three dosing regimens to receive concentration-controlled MMF with reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard CNI. Participants will be followed for 20-24 months after randomization.
- Conditions
- Kidney Transplantation
- Being tested
- Mycophenolate mofetil, Cyclosporine, Tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called CellCept
Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or IV form. The initial dose will be at least 1 gram BID in adults and 600 mg/m^2 in pediatrics. In Groups A and B, subsequent doses will be adjusted to maintain blood MPA levels ≥1.3 μg/mL with cyclosporine or ≥1.9 μg/mL with tacrolimus. In Group C, subsequent doses are not to be adjusted, except in the case of unacceptable toxicity.
CyclosporineDrug
Also called Neoral
Cyclosporine will be given as 100-mg soft gelatin capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 ng/mL; Days 30-90, 125-165 ng/mL (reduced) or 250-270 ng/mL (full); Days 90 through end of study, 95-145 ng/mL (reduced) or 190-220 ng/mL (full).
TacrolimusDrug
Also called Prograf
Tacrolimus will be given as 1-mg and 5-mg capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Tacrolimus target concentrations are as follows: Days 1-30, 8-12 ng/mL; Days 30-90, 4-6 ng/mL (reduced), 8-10 ng/mL (full); Days 90 through end of study, 3-5 ng/mL (reduced), 6-8 ng/mL (full).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Monitored MMF + Reduced CNI | Experimental | Group A will receive concentration-controlled/monitored MMF with an oral CNI, either cyclosporine or tacrolimus. Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or intravenous (IV) form. The initial dose will be at least 1 gram twice a day (BID) in adults and 600 milligrams per meter-squared (mg/m^2) in pediatrics. Subsequent doses will be adjusted to maintain blood mycophenolic acid (MPA) levels greater than or equal to (≥) 1.3 micrograms per milliliter (μg/mL) with cyclosporine or ≥1.9 μg/mL with tacrolimus. The selected CNI will be dosed to maintain reduced blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 nanograms per milliliter (ng/mL); Days 30-90, 125-165 ng/mL; Days 90 through end of study, 95-145 ng/mL. Tacrolimus target concentrations areas follows: Days 1-30, 8-12 ng/mL; Days 30-90, 4-6 ng/mL; Days 90 through end of study, 3-5 ng/mL. Receives: Drug: Mycophenolate mofetil; Drug: Cyclosporine; Drug: Tacrolimus |
| Group B: Monitored MMF + Full CNI | Experimental | Group B will receive concentration-controlled/monitored MMF with an oral CNI, either cyclosporine or tacrolimus. Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or IV form. The initial dose will be at least 1 gram BID in adults and 600 mg/m^2 in pediatrics. Subsequent doses will be adjusted to maintain blood MPA levels ≥1.3 μg/mL with cyclosporine or ≥1.9 μg/mL with tacrolimus. The selected CNI will be dosed to maintain standard/full blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 ng/mL; Days 30-90, 250-270 ng/mL; Days 90 through end of study, 190-220 ng/mL. Tacrolimus target concentrations are as follows: Days 1-30, 8-12 ng/mL; Days 30-90, 8-10 ng/mL; Days 90 through end of study, 6-8 ng/mL. Receives: Drug: Mycophenolate mofetil; Drug: Cyclosporine; Drug: Tacrolimus |
| Group C: Fixed MMF + Full CNI | Experimental | Group C will receive fixed-dose MMF with an oral CNI, either cyclosporine or tacrolimus. Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or IV form. The dose will be at least 1 gram BID in adults and 600 mg/m^2 in pediatrics. Subsequent doses are not to be adjusted, except in the case of unacceptable toxicity. The selected CNI will be dosed to maintain standard/full blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 ng/mL; Days 30-90, 250-270 ng/mL; Days 90 through end of study, 190-220 ng/mL. Tacrolimus target concentrations are as follows: Days 1-30, 8-12 ng/mL; Days 30-90, 8-10 ng/mL; Days 90 through end of study, 6-8 ng/mL. Receives: Drug: Mycophenolate mofetil; Drug: Cyclosporine; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Treatment Failure During 12 Months Post-Transplantation
Measured: Month 12
Percent Change from Baseline in Calculated Glomerular Filtration Rate (GFR) at 12 Months Post-Transplantation
Measured: Baseline to Month 12
Secondary outcomes (10)
Percentage of Participants with Treatment Failure During 6 and 20-24 Months Post-Transplantation
Measured: Months 6, 20-24
Percentage of Participants with Biopsy-Proven Acute Rejection (BPAR)
Measured: Months 6, 12, 20-24
Percentage of Participants by Number of BPAR Episodes
Measured: Months 6, 12, 20-24
Percentage of Participants Treated for Acute Rejection (AR)
Measured: Months 6, 12, 20-24
Percentage of Participants Who Experienced Graft Loss
Measured: Months 6, 12, 20-24
Percentage of Participants Who Died
Measured: Months 6, 12, 20-24
Percentage of Participants Who Discontinued Treatment with MMF
Measured: Months 6, 12, 20-24
Time to First BPAR Episode
Measured: Months 6, 12, 20-24
Time to Treatment Failure
Measured: Months 6, 12, 20-24
Percent Change from Baseline in Calculated GFR at 3, 6, and 20-24 Months Post-Transplantation
Measured: Baseline to Months 3, 6, 20-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2004 (estimated)
- Study startJun 2004
- Primary completionSep 2007
- Study completionSep 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 Hoffmann-La RocheThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087581
- Sponsor's protocol ID
- ML17225
- Status last verified
- Sep 2016
- First submitted
- 12 Jul 2004
- Last updated
- 7 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Prospective, Randomized, Controlled, Multi-Center Study Assessing Fixed Dose Versus Concentration Controlled Cellcept® Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors
- ClinicalTrials.gov ID
- NCT00087581
- Acronym / sponsor ID
- ML17225
- Conditions
- Kidney Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 14 Jul 2004 (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.
This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Participants will be randomized to one of three dosing regimens to receive concentration-controlled MMF with reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard CNI. Participants will be followed for 20-24 months after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Monitored MMF + Reduced CNI | Experimental | Drug: Mycophenolate mofetil, Drug: Cyclosporine, Drug: TacrolimusGroup A will receive concentration-controlled/monitored MMF with an oral CNI, either cyclosporine or tacrolimus. Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or intravenous (IV) form. The initial dose will be at least 1 gram twice a day (BID) in adults and 600 milligrams per meter-squared (mg/m^2) in pediatrics. Subsequent doses will be adjusted to maintain blood mycophenolic acid (MPA) levels greater than or equal to (≥) 1.3 micrograms per milliliter (μg/mL) with cyclosporine or ≥1.9 μg/mL with tacrolimus. The selected CNI will be dosed to maintain reduced blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 nanograms per milliliter (ng/mL); Days 30-90, 125-165 ng/mL; Days 90 through end of study, 95-145 ng/mL. Tacrolimus target concentrations areas follows: Days 1-30, 8-12 ng/mL; Days 30-90, 4-6 ng/mL; Days 90 through end of study, 3-5 ng/mL. |
| Group B: Monitored MMF + Full CNI | Experimental | Drug: Mycophenolate mofetil, Drug: Cyclosporine, Drug: TacrolimusGroup B will receive concentration-controlled/monitored MMF with an oral CNI, either cyclosporine or tacrolimus. Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or IV form. The initial dose will be at least 1 gram BID in adults and 600 mg/m^2 in pediatrics. Subsequent doses will be adjusted to maintain blood MPA levels ≥1.3 μg/mL with cyclosporine or ≥1.9 μg/mL with tacrolimus. The selected CNI will be dosed to maintain standard/full blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 ng/mL; Days 30-90, 250-270 ng/mL; Days 90 through end of study, 190-220 ng/mL. Tacrolimus target concentrations are as follows: Days 1-30, 8-12 ng/mL; Days 30-90, 8-10 ng/mL; Days 90 through end of study, 6-8 ng/mL. |
| Group C: Fixed MMF + Full CNI | Experimental | Drug: Mycophenolate mofetil, Drug: Cyclosporine, Drug: TacrolimusGroup C will receive fixed-dose MMF with an oral CNI, either cyclosporine or tacrolimus. Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or IV form. The dose will be at least 1 gram BID in adults and 600 mg/m^2 in pediatrics. Subsequent doses are not to be adjusted, except in the case of unacceptable toxicity. The selected CNI will be dosed to maintain standard/full blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 ng/mL; Days 30-90, 250-270 ng/mL; Days 90 through end of study, 190-220 ng/mL. Tacrolimus target concentrations are as follows: Days 1-30, 8-12 ng/mL; Days 30-90, 8-10 ng/mL; Days 90 through end of study, 6-8 ng/mL. |
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females 13-75 years of age
- Single organ recipient (kidney only) from living (related or unrelated) or cadaveric heart-beating donors
- Receiving first or second kidney transplant
Key exclusion criteria (2 listed)
- Immunosuppressive therapy (except for 48 hours prior to transplantation and corticosteroid treatment) within previous 28 days for a first transplant and 3 months for a second transplant
- History of malignancy in last 5 years (except successfully treated localized non-melanoma skin cancer)
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 |
|---|---|---|
| Mycophenolate mofetilAlso: CellCeptDepending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or IV form. The initial dose will be at least 1 gram BID in adults and 600 mg/m^2 in pediatrics. In Groups A and B, subsequent doses will be adjusted to maintain blood MPA levels ≥1.3 μg/mL with cyclosporine or ≥1.9 μg/mL with tacrolimus. In Group C, subsequent doses are not to be adjusted, except in the case of unacceptable toxicity. | Drug | Group A: Monitored MMF + Reduced CNI, Group B: Monitored MMF + Full CNI, Group C: Fixed MMF + Full CNI |
| CyclosporineAlso: NeoralCyclosporine will be given as 100-mg soft gelatin capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 ng/mL; Days 30-90, 125-165 ng/mL (reduced) or 250-270 ng/mL (full); Days 90 through end of study, 95-145 ng/mL (reduced) or 190-220 ng/mL (full). | Drug | Group A: Monitored MMF + Reduced CNI, Group B: Monitored MMF + Full CNI, Group C: Fixed MMF + Full CNI |
| TacrolimusAlso: PrografTacrolimus will be given as 1-mg and 5-mg capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Tacrolimus target concentrations are as follows: Days 1-30, 8-12 ng/mL; Days 30-90, 4-6 ng/mL (reduced), 8-10 ng/mL (full); Days 90 through end of study, 3-5 ng/mL (reduced), 6-8 ng/mL (full). | Drug | Group A: Monitored MMF + Reduced CNI, Group B: Monitored MMF + Full CNI, Group C: Fixed MMF + Full CNI |
Primary outcome
Percentage of Participants with Treatment Failure During 12 Months Post-Transplantation
Time frame: Month 12
Percent Change from Baseline in Calculated Glomerular Filtration Rate (GFR) at 12 Months Post-Transplantation
Time frame: Baseline to Month 12
10 secondary outcomes
Percentage of Participants with Treatment Failure During 6 and 20-24 Months Post-Transplantation
Time frame: Months 6, 20-24
Percentage of Participants with Biopsy-Proven Acute Rejection (BPAR)
Time frame: Months 6, 12, 20-24
Percentage of Participants by Number of BPAR Episodes
Time frame: Months 6, 12, 20-24
Percentage of Participants Treated for Acute Rejection (AR)
Time frame: Months 6, 12, 20-24
Percentage of Participants Who Experienced Graft Loss
Time frame: Months 6, 12, 20-24
Percentage of Participants Who Died
Time frame: Months 6, 12, 20-24
Percentage of Participants Who Discontinued Treatment with MMF
Time frame: Months 6, 12, 20-24
Time to First BPAR Episode
Time frame: Months 6, 12, 20-24
Time to Treatment Failure
Time frame: Months 6, 12, 20-24
Percent Change from Baseline in Calculated GFR at 3, 6, and 20-24 Months Post-Transplantation
Time frame: Baseline to Months 3, 6, 20-24
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 7 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
57 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 Mycophenolate mofetil, Cyclosporine and Tacrolimus in people with Kidney Transplantation, run by Hoffmann-La Roche at 57 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 3 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 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 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?
Percentage of Participants with Treatment Failure During 12 Months Post-Transplantation (time frame: Month 12). The study lists 2 primary outcomes in all. 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 Nov 2016.