Renal TransplantPhase 4MMFNCT00737659
CellCept® Dose Adjustment Versus Fixed Dose (Standard Care) in Renal Transplant Recipients
A Phase 4 study testing Mycophenolate mofetil (CellCept® ) in people with Renal Transplant, run by Rabin Medical Center at 2 sites in Israel.
Trial summary
In order to avoid renal transplant rejection, the immune system should be suppressed. After the renal transplant subjects are treated with a combination of two to four different types of immunosuppressive drugs. Theses drugs are very efficient in the prevention of the renal transplant rejection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Mycophenolate mofetil (CellCept® )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesIsrael
- Study dates
- Aug 2008to Aug 2013
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, between 18 to 70 years of age at the time of enrollment.
- Patient who received first or second renal transplant.
- Patients who are 0-14 days post transplant.
- Patients capable of understanding the purposes and risks of the study who signed a written informed consent to participate and to comply with the requirements of the study.
Who cannot join
- Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method before beginning study drug therapy, during therapy and for 4 months following their last dose of the study drug therapy.
- Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy.
- Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- Patients with evidence of an active systemic infection requiring the continued use of antibiotics or evidence of an HIV infection, or the presence of a chronic active hepatitis B (HBs-Ag positive) or C.
- Current or historic Panel Reactive Antibody (PRA) >50%
- Positive crossmatch (irrespective of method).
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- Cold ischemia time of the graft of more than 30 hours.
- Patients who had received an investigational new drug within the last three months at the time of enrollment.
- Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
- Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).
- Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of <1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.
- Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
- Previous exposure to EC-MPS.
Trial locations and contacts
2 sites in 1 country.
Eytan Mor, Prof. contact
Alexander Yussim, Dr. contact
Israel2 sites, 2 recruiting
- Recruiting
Rabin Medical Center
Petach Tikvah
Eytan Mor, Prof., +972-39376528
Alexander Yussim, Dr., +972-39376452
- Recruiting
Tel Aviv sourasky Medical Center
Tel Aviv
Richard Nakache, MD, 972-3-6974408
Ravit Tvito, RC, 972-508356663
About this study
Official title: Phase IV, Open-Label, Multicenter, Randomized Study Comparing Mycophenolate Mofetil (MMF) Dose Adjustment Based on Blood MPA Concentration to Standard Care Treatment With MMF in Renal Transplant Recipients Receiving Tacrolimus
In order to avoid renal transplant rejection, the immune system should be suppressed. After the renal transplant subjects are treated with a combination of two to four different types of immunosuppressive drugs. Theses drugs are very efficient in the prevention of the renal transplant rejection. Still, they can cause side effect.
Research in renal transplant tries to find the best treatment in order to avoid renal rejection on one hand and to reduce as much as possible the undesired adverse and toxicity effects on the other hand.
Read more
Therapeutic efficacy and the onset of adverse effects are influenced by levels of mycophenolic acid (MPA, the active metabolite of MMF, CellCept®).
The primary objective of this study is to assess the treatment superiority of CellCept® Dose Adjustment treatment, based on individual MPA concentration value monitored periodically, against treatment with CellCept® Fixed Dose (standard care).
Read the detailed description
Patient will be randomized into two treatment groups on a 1:1 ratio. Both groups will be treated with the same drugs which is the usual treatment for avoiding renal transplant rejection. In one group the CellCept® dose will be adjusted based on MPA concentration value which will be monitored periodically; and the second group will be treated with CellCept® Fixed Dose (based on the clinical judgment of the treating physician).
- Conditions
- Renal Transplant
- Being tested
- Mycophenolate mofetil (CellCept® )
- Keywords
- Renal Transplant, Renal, Transplant, MMF, MPA, Recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate mofetil (CellCept® )Drug
Also called CellCept®, MMF
Concentration Control group: MMF dosage will be adjusted (by addition or subtraction of least 250 mg of MMF twice a day) based on MPA levels (MPA AUC target of 40 mg*h\L) measured on Days 7,14,Months 1,3,6 and 12.
Mycophenolate mofetil (CellCept® )Drug
Fixed Dose group, MMF dosage will be adjusted based on standard care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Concentration Controlled (CC)group will receive an individually adjusted MMF dosing regimen based on the plasma concentrations of mycophenolic acid (MPA,the active metabolite of mycophenolate mofetil). Receives: Drug: Mycophenolate mofetil (CellCept® ) |
| 2 | Active comparator | Fixed dose (FD) group will receive an a priori set dose of 2mg\day MMF, the recommended dose, with a possible secondary adaptation by the clinician based on criteria of clinical efficacy, toxicity or interactions with other medications. Receives: Drug: Mycophenolate mofetil (CellCept® ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint Treatment failure defined as a biopsy proven acute rejection, graft loss, death, MMF discontinuation or lost to follow-up.
Measured: During the first 12 months following randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2011 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies 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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Eytan Mor, Prof., Principal investigator, Rabin Medical CenterRichard Nakache, Prof., Principal investigator, Sorasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737659
- Sponsor's protocol ID
- ML21706
- Acronym
- MMF
- Status last verified
- Dec 2008
- First submitted
- 17 Aug 2008
- Last updated
- 26 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Open-Label, Multicenter, Randomized Study Comparing Mycophenolate Mofetil (MMF) Dose Adjustment Based on Blood MPA Concentration to Standard Care Treatment With MMF in Renal Transplant Recipients Receiving Tacrolimus
- ClinicalTrials.gov ID
- NCT00737659
- Acronym / sponsor ID
- MMF / ML21706
- Conditions
- Renal Transplant
- Keywords
- Renal Transplant, Renal, Transplant, MMF, MPA, Recipients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 19 Aug 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.
In order to avoid renal transplant rejection, the immune system should be suppressed. After the renal transplant subjects are treated with a combination of two to four different types of immunosuppressive drugs. Theses drugs are very efficient in the prevention of the renal transplant rejection. Still, they can cause side effect.
Research in renal transplant tries to find the best treatment in order to avoid renal rejection on one hand and to reduce as much as possible the undesired adverse and toxicity effects on the other hand.
Therapeutic efficacy and the onset of adverse effects are influenced by levels of mycophenolic acid (MPA, the active metabolite of MMF, CellCept®).
The primary objective of this study is to assess the treatment superiority of CellCept® Dose Adjustment treatment, based on individual MPA concentration value monitored periodically, against treatment with CellCept® Fixed Dose (standard care).
Detailed description
Patient will be randomized into two treatment groups on a 1:1 ratio. Both groups will be treated with the same drugs which is the usual treatment for avoiding renal transplant rejection. In one group the CellCept® dose will be adjusted based on MPA concentration value which will be monitored periodically; and the second group will be treated with CellCept® Fixed Dose (based on the clinical judgment of the treating physician).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Mycophenolate mofetil (CellCept® )Concentration Controlled (CC)group will receive an individually adjusted MMF dosing regimen based on the plasma concentrations of mycophenolic acid (MPA,the active metabolite of mycophenolate mofetil). |
| 2 | Active comparator | Drug: Mycophenolate mofetil (CellCept® )Fixed dose (FD) group will receive an a priori set dose of 2mg\day MMF, the recommended dose, with a possible secondary adaptation by the clinician based on criteria of clinical efficacy, toxicity or interactions with other medications. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects, between 18 to 70 years of age at the time of enrollment.
- Patient who received first or second renal transplant.
- Patients who are 0-14 days post transplant.
- Patients capable of understanding the purposes and risks of the study who signed a written informed consent to participate and to comply with the requirements of the study.
Key exclusion criteria (13 listed)
- Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method before beginning study drug therapy, during therapy and for 4 months following their last dose of the study drug therapy.
- Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy.
- Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- Patients with evidence of an active systemic infection requiring the continued use of antibiotics or evidence of an HIV infection, or the presence of a chronic active hepatitis B (HBs-Ag positive) or C.
- Current or historic Panel Reactive Antibody (PRA) >50%
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 mofetil (CellCept® )Also: CellCept®, MMFConcentration Control group: MMF dosage will be adjusted (by addition or subtraction of least 250 mg of MMF twice a day) based on MPA levels (MPA AUC target of 40 mg*h\L) measured on Days 7,14,Months 1,3,6 and 12. | Drug | 1 |
| Mycophenolate mofetil (CellCept® )Fixed Dose group, MMF dosage will be adjusted based on standard care | Drug | 2 |
Primary outcome
Primary Endpoint Treatment failure defined as a biopsy proven acute rejection, graft loss, death, MMF discontinuation or lost to follow-up.
Time frame: During the first 12 months following randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2010.
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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.
Eytan Mor, Prof. contact
Alexander Yussim, Dr. contact
Eytan Mor, Prof. principal investigator
Rabin Medical Center
Richard Nakache, Prof. principal investigator
Sorasky Medical Center
2 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 (CellCept® ) in people with Renal Transplant, run by Rabin Medical Center at 2 sites in Israel.
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: status not confirmed, as of the sponsor's last update on 26 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eytan Mor, Prof. (+972-39376452), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint Treatment failure defined as a biopsy proven acute rejection, graft loss, death, MMF discontinuation or lost to follow-up. (time frame: During the first 12 months following randomization.). 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 Mar 2010; AzTrials last refreshed its copy on 6 Nov 2026.