End Stage Renal DiseasePhase 2/3NCT00533624
Myfortic vs. Cellcept in Kidney Transplant Recipients
A Phase 2/3 study testing Mycophenolate Sodium Delayed Release Tablets and Mycophenolate Mofetil in people with End Stage Renal Disease, run by University of Miami at 1 site in United States.
Trial summary
The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150 sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first and second living or deceased donor renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Mycophenolate Sodium Delayed Release Tablets and Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Feb 2006
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has been fully informed and has signed a dated IRB approval informed consent form and is willing to follow study procedures for the extent of the study (12 months). Parent or legal guardian must provide written consent for patients <18 years of age.
- Age 18-75 years.
- Weight > 40 kg.
- Primary or secondary renal allograft: living or deceased donor.
- Negative standard crossmatch for T cells.
- Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception for the study duration.
- Males and females are to be studied equivalently as they become available for transplantation using these criteria.
Who cannot join
- Patient has previously received or is receiving an organ transplant other than a kidney.
- Patient is receiving an ABO incompatible donor kidney.
- Recipient or donor is seropositive for human immunodeficiency (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
- 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, or carcinoma in situ of the cervix that has been treated successfully.
- Patients with 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 this center.
- Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
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- Patient is currently participating in another clinical trial of an investigational drug in the 30 days prior to transplant.
- Patient will be receiving any immunosuppressive agent other than those prescribed in the study.
- Patient is unable to take medications orally or via nasogastric tube by the morning of the second day following completion of the transplant procedure (i.e., skin closure) (Group I only).
- Patient is receiving or may require warfarin, fluvastatin, or herbal supplements during the study.
- Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
- Patient has a known hypersensitivity to tacrolimus, thymoglobulin, IL-2 receptor inhibitor monoclonal antibodies, sirolimus, MMF, Myfortic®, or corticosteroids.
- Patient is pregnant or lactating.
- Patients with a screening/baseline (or within 96 hours of transplant) total white blood cell count <4000/mm3; platelet count <100,000/mm3; fasting triglycerides >400 mg/dl (>4.6 mmol/L); fasting total cholesterol >300 mg/dl (>7.8 mmol/L); fasting HDL-cholesterol <30 mg/dl; fasting LDL-cholesterol >200 mg/dl.
- 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.
- If tacrolimus cannot be instituted for longer than 5 days postoperatively.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol
The comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150 sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first and second living or deceased donor renal transplant recipients.
Read the detailed description
Purpose and Description:
The purpose of the study is to determine if gastrointestinal toxicity of an anti-rejection medication Myfortic® (mycophenolic acid delayed release) is less than equivalent doses of a similar anti-rejection medication Cellcept® (mycophenolate mofetil, MMF) in patients receiving their first or second kidney transplant from cadaver or living donors.
This study consist of two randomized groups, 75 patients given 3 doses of Thymoglobullin (Group I) vs. 75 patients given 3 doses of Thymoglobulin and 2 doses of Basiliximab (Group II).
Our standard maintenance protocol dosing of tacrolimus, IMPDH inhibitor (vide infra) and one week course of corticosteroids.
Patients will be randomized to receive Myfortic® 1,440 mg/day vs. Cellcept® 2,000 mg/day, each in two divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively.
- Conditions
- End Stage Renal Disease
- Being tested
- Mycophenolate Sodium Delayed Release Tablets, Mycophenolate Mofetil
- Keywords
- Gastrointestinal toxicity
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate Sodium Delayed Release TabletsDrug
Myfortic® 1,440 mg/day
Also called Cellcept®
Cellcept® 2,000 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1: Myfortic | Active comparator | Myfortic Group: Myfortic® 1,440 mg/day in two divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively. Receives: Drug: Mycophenolate Sodium Delayed Release Tablets |
| 2. Cellcept | Active comparator | Cellcept® 2,000 mg/day, in divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively. Receives: Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra).
Measured: 1 year
Secondary outcomes (1)
Incidence of AE: Infections, malignancies (including PTLD), thromboembolic events, hyperlipidemia and leuko and thrombocytopenia, cytokine release syndrome with induction antibody agents, wound healing and lymphocele, post-tx diabetes.
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 posted21 Sep 2007 (estimated)
- Study startDec 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Investigators
- George W Burke, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533624
- Sponsor's protocol ID
- CERL080A-US10
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2007
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Ciancio G, Gaynor JJ, Sageshima J, Roth D, Kupin W, Guerra G, Tueros L, Zarak A, Hanson L, Ganz S, Chen L, Ruiz P, Livingstone AS, Burke GW 3rd. Machine perfusion following static cold storage preservation in kidney transplantation: donor-matched pair analysis of the prognostic impact of longer pump time. Transpl Int. 2012 Jan;25(1):34-40. doi: 10.1111/j.1432-2277.2011.01364.x. Epub 2011 Oct 8.
PubMed 21981661
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head to Head Comparison of Myfortic vs. Cellcept in the Treatment of Kidney Transplant Recipients Using Our Current Center Standardized Concomitant Immunosuppressive Protocol
- ClinicalTrials.gov ID
- NCT00533624
- Acronym / sponsor ID
- CERL080A-US10
- Conditions
- End Stage Renal Disease
- Keywords
- Gastrointestinal toxicity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Dec 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 21 Sep 2007 (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 comparison the incidence of G.I. toxicity between Myfortic® vs. Cellcept® in 150 sequential patients, in which 75 will be randomized to Cellcept® and 75 to Myfortic® in first and second living or deceased donor renal transplant recipients.
Detailed description
Purpose and Description:
The purpose of the study is to determine if gastrointestinal toxicity of an anti-rejection medication Myfortic® (mycophenolic acid delayed release) is less than equivalent doses of a similar anti-rejection medication Cellcept® (mycophenolate mofetil, MMF) in patients receiving their first or second kidney transplant from cadaver or living donors.
This study consist of two randomized groups, 75 patients given 3 doses of Thymoglobullin (Group I) vs. 75 patients given 3 doses of Thymoglobulin and 2 doses of Basiliximab (Group II).
Our standard maintenance protocol dosing of tacrolimus, IMPDH inhibitor (vide infra) and one week course of corticosteroids.
Patients will be randomized to receive Myfortic® 1,440 mg/day vs. Cellcept® 2,000 mg/day, each in two divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Myfortic | Active comparator | Drug: Mycophenolate Sodium Delayed Release TabletsMyfortic Group: Myfortic® 1,440 mg/day in two divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively. |
| 2. Cellcept | Active comparator | Drug: Mycophenolate MofetilCellcept® 2,000 mg/day, in divided doses (induced with either the IL-2 receptor inhibitors or thymoglobulin). Tacrolimus will be dosed to 12-hour trough levels of 8-10 ng/ml. Methylprednisolone is to be given as per our center protocols, weaning to dose levels of <0.1 mg/kg by 3-6 months post-operatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has been fully informed and has signed a dated IRB approval informed consent form and is willing to follow study procedures for the extent of the study (12 months). Parent or legal guardian must provide written consent for patients <18 years of age.
- Age 18-75 years.
- Weight > 40 kg.
- Primary or secondary renal allograft: living or deceased donor.
- Negative standard crossmatch for T cells.
Key exclusion criteria (17 listed)
- Patient has previously received or is receiving an organ transplant other than a kidney.
- Patient is receiving an ABO incompatible donor kidney.
- Recipient or donor is seropositive for human immunodeficiency (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
- 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, or carcinoma in situ of the cervix that has been treated successfully.
- Patients with 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 this center.
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 Sodium Delayed Release TabletsMyfortic® 1,440 mg/day | Drug | 1: Myfortic |
| Mycophenolate MofetilAlso: Cellcept®Cellcept® 2,000 mg/day | Drug | 2. Cellcept |
Primary outcome
Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra).
Time frame: 1 year
1 secondary outcome
Incidence of AE: Infections, malignancies (including PTLD), thromboembolic events, hyperlipidemia and leuko and thrombocytopenia, cytokine release syndrome with induction antibody agents, wound healing and lymphocele, post-tx diabetes.
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 28 Sep 2023.
- Derived from this study: PubMed 21981661Ciancio G, Gaynor JJ, Sageshima J, Roth D, Kupin W, Guerra G, Tueros L, Zarak A, Hanson L, Ganz S, Chen L, Ruiz P, Livingstone AS, Burke GW 3rd. Machine perfusion following static cold storage preservation in kidney transplantation: donor-matched pair analysis of the prognostic impact of longer pump time. Transpl Int. 2012 Jan;25(1):34-40. doi: 10.1111/j.1432-2277.2011.01364.x. Epub 2011 Oct 8.
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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.
George W Burke, M.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mycophenolate Sodium Delayed Release Tablets and Mycophenolate Mofetil in people with End Stage Renal Disease, run by University of Miami at 1 site 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 7 inclusion and 17 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
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?
Observation of G.I. toxicity (nausea, vomiting, or diarrhea). One year patient and graft survival after initiation of study agent.Incidence of biopsy-proven acute rejection (vide infra). 4. Incidence of chronic allograft nephropathy (vide infra). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00533624, which also lists 1 linked publication.
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 28 Sep 2023.