N/A
Completed N=30
A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
Source: ClinicalTrials.gov NCT00336817 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil — 21.80; 23.07; 24.90; 22.14 units on a scale
Summary
The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs. CellCept is commonly used after liver transplantation but gastrointestinal (GI) side effects are very common, sometimes necessitating in its discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable effectiveness to CellCept.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil |
21.80; 23.07; 24.90; 22.14; 28.90; 26.07 | — |
| PRIMARY GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Abdominal Pain Subscale) |
5.20; 5.29; 5.80; 4.79; 6.40; 5.93 | — |
| PRIMARY GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Reflux Subscale) |
2.70; 3.07; 2.90; 2.36; 2.90; 3.36 | — |
| PRIMARY GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Indigestion Subscale) |
5.40; 5.86; 5.80; 6.43; 6.50; 7.50 | — |
| PRIMARY GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Diarrhea Subscale) |
4.00; 4.79; 5.80; 4.36; 6.60; 4.50 | — |
| PRIMARY GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Constipation Subscale) |
4.50; 4.07; 4.60; 4.21; 6.50; 4.79 | — |
| PRIMARY Number of Participants With Bone Marrow Suppression |
0; 0 | — |
| PRIMARY Incidence of Cytomegalovirus Infection or Disease During the Study Period |
0; 0 | — |
| SECONDARY Drug Discontinuation Due to Side Effects |
1; 2 | — |
| SECONDARY Number of Participants With Clinically Significant Decrease in Serum Creatinine From Baseline Through Week 12 |
0; 0 | — |
| SECONDARY Number of Participants With Neurotoxicity |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age.
- Patients must be 30 to 180 days (1 to 6 months) post-transplant to be eligible.
- Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen.
- Patients with renal insufficiency (history of renal insufficiency or renal failure in the past, patients on hemodialysis, patients with a rising creatinine post-transplant).
- Patients with biopsy-proven acute cellular rejection (mild, moderate, or severe based on Rejection Activity Index (RAI) as graded by pathologists at UPMC) or repeated bouts of rejection (greater than 2 episodes within a 30 day period).
- Patients with tacrolimus- or cyclosporine-induced neurotoxicity.
- Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period.
Exclusion Criteria
- Multi-organ transplant patients.
- HIV positive patients.
- Living-related liver transplant recipients
- Pregnant patients and nursing mothers.
- Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
- Patients with thrombocytopenia (<50, 000/mm3), with an absolute neutrophil count of <1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to enrollment.
- Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.
- Evidence of drug and/or alcohol abuse.
- Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves
Data sourced from ClinicalTrials.gov (NCT00336817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.