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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR MYCOPHENOLIC ACID

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Clinical Trials for Mycophenolic Acid

Trial ID Title Status Sponsor Phase Summary
NCT00007059 Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation Completed University of North Carolina N/A OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation. II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.
NCT00007059 Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation Completed National Center for Research Resources (NCRR) N/A OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation. II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.
NCT00021489 Mycophenolate Mofetil and Abacavir Treatment in HIV Patients With Failed Anti-HIV Treatment Withdrawn National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 The purpose of this study is to learn how safe and well-tolerated mycophenolate mofetil (MMF) is when given with abacavir (ABC). Another purpose is to see if adding MMF to ABC decreases viral load (amount of HIV in the blood) more than ABC alone. Many HIV-infected patients who have had heavy exposure to anti-HIV drugs and have experienced treatment failure need new treatment combinations. One promising combination is ABC and MMF as part of a drug combination. Laboratory studies show that MMF helps ABC destroy HIV in the cells and further clinical testing is needed. MMF is not FDA-approved as a treatment for HIV infection but has been approved by FDA to prevent rejection of organ transplants. Doses of MMF tested in this study will be lower than those used to treat people with organ transplants.
NCT00128947 Pharmacokinetics of Mycophenolate Mofetil in Healthy Volunteers Completed National Institutes of Health Clinical Center (CC) Phase 1 This study will examine how people differ in the way their bodies process and eliminate mycophenolate mofetil (MMF), a drug that is used to treat problems affecting the eye and immune system and to prevent organ rejection in transplant patients. MMF is metabolized by a group of enzymes called UGTs, each of which is made by a different gene. This study will investigate whether people with different UGT genes differ in how well their bodies use and remove MMF. The results may help scientists learn the best way to give MMF to patients. Normal healthy volunteers between 18 and 55 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests, including a blood test for analysis of genes that control and regulate UGTs. Pregnant women and nursing mothers are excluded from the study. Women who are able to have a child and men who can father a child must either abstain from sex or use two reliable forms of birth control during the study and for 3 months after its completion. Participants come to the NIH Clinical Center at 6:30 a.m. on the first day of the study and stay in the outpatient clinic for 12 hours. The next 4 mornings, they return to the Clinical Center for a single blood collection. The procedures for the 5 days are as follows: Day 1 Upon arrival at the Clinical Center a catheter is inserted into the subject's arm vein. At 7:00 AM, the subject takes one dose of MMF by mouth with a glass of water. Small blood samples are collected through the catheter before the MMF dose and again at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours after taking the drug. Heart rate and blood pressure are measured before the blood collection and then every 4 hours. After the last blood sample is collected, the volunteer can return home. Days 2-5 Volunteers come to the Clinical Center at 7:00 AM on study days 2, 3, 4, and 5 for a single blood draw, collected using a needle. Volunteers are contacted by telephone 1, 2, and 3 months after completing the study to see how they are doing and to check on their pregnancy status and use of appropriate birth control.
NCT00166153 Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept Terminated Emory University N/A The survival of children who have received heart transplants has greatly improved over the last ten years. One reason for this is better control over rejection. Rejection medications require a delicate balance of enough medicine to work without causing side effects. It is a goal to avoid both rejection and side effects from the anti-rejection medicines. Usually several medicines are used together to prevent rejection. One of these medicines is often Mycophenolic Acid or CellceptThis medicine has been used longer for adults than is has for children. More information is needed on using it for children. The dose is usually determined by the patient's weight or body surface area. There have been some early studies of the use of Cellcept, but none have proven a relationship between the blood level of the drug and how well it works. More also needs to be known about how this drug works with other anti-rejection drugs and how it works in boys and girls. This study will look more closely at proper dosing, how Cellcept works with other anti-rejection medications, side effects, and any differences in how this medicine works in boys and girls. All patients in the study will be receiving Cellcept and have blood levels of the drug drawn. Results of their usual treatment and testing will be recorded and evaluated for signs of rejection. All the information will be analyzed. Results of this study will be reported to transplant committees locally and nationally.
NCT00166244 Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation Completed Hoffmann-La Roche Phase 4 Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.
NCT00166244 Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation Completed Erasmus Medical Center Phase 4 Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Mycophenolic Acid

Condition Name

Condition Name for Mycophenolic Acid
Intervention Trials
Kidney Transplantation 16
Liver Transplantation 6
Lupus Nephritis 5
Renal Transplantation 5
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Condition MeSH

Condition MeSH for Mycophenolic Acid
Intervention Trials
Renal Insufficiency 6
Nephritis 6
Lupus Nephritis 5
Kidney Failure, Chronic 4
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Clinical Trial Locations for Mycophenolic Acid

Trials by Country

Trials by Country for Mycophenolic Acid
Location Trials
United States 114
Canada 18
Spain 16
Germany 14
France 9
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Trials by US State

Trials by US State for Mycophenolic Acid
Location Trials
California 13
Wisconsin 9
New York 7
Ohio 7
Pennsylvania 7
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Clinical Trial Progress for Mycophenolic Acid

Clinical Trial Phase

Clinical Trial Phase for Mycophenolic Acid
Clinical Trial Phase Trials
Phase 4 42
Phase 3 13
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Mycophenolic Acid
Clinical Trial Phase Trials
Completed 50
Recruiting 15
Terminated 10
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Clinical Trial Sponsors for Mycophenolic Acid

Sponsor Name

Sponsor Name for Mycophenolic Acid
Sponsor Trials
Novartis Pharmaceuticals 18
Novartis 13
Hoffmann-La Roche 11
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Sponsor Type

Sponsor Type for Mycophenolic Acid
Sponsor Trials
Other 107
Industry 53
NIH 8
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