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Label indication Myfortic is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1 ) Use in combination with cyclosporine and corticosteroids.
Also known as Mycophenolate sodium, Mycophenolate sodium (enteric coated), Myfortic
Mycophenolate · 6 trials · 3 indications
Complete remission was defined as urine protein/urine creatinine ratio \< 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, \< 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.
| Arm | Type | Description |
|---|---|---|
| Mycophenolate sodium (enteric coated) | EXPERIMENTAL | - |
| Standard dose | EXPERIMENTAL | Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks. |
| Low dose | ACTIVE_COMPARATOR | Mycophenolate sodium was administered in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Mycophenolate sodium (enteric coated) | DRUG | - |
| Myfortic | DRUG | - |
| Mycophenolate sodium | DRUG | Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks. |
| Prednisone | DRUG | Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight. |
| Methylprednisolone | DRUG | All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days. |
Inclusion Criteria: * Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant, * treated with cyclosporine and corticosteroids as primary immunosuppression. Exclusion Criteria: * Second or subsequent kidney transplant or multi-o...
Mycophenolate is studied for lupus nephritis and renal transplant. In lupus nephritis, it has been evaluated in combination with corticosteroid regimens for the treatment of flare. In renal transplant, it has been studied as an immunosuppressive therapy in adult patients, including de novo transplant recipients and follow-up safety studies.
Mycophenolate targets IMPDH1 and IMPDH2, the two isoforms of inosine monophosphate dehydrogenase. It acts as an inhibitor of these enzymes. By inhibiting IMPDH1 and IMPDH2, mycophenolate interferes with guanine nucleotide synthesis, which is relevant to its immunosuppressive activity in lymphocyte proliferation.
Mycophenolate is developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored the clinical trial program for enteric-coated mycophenolate sodium across lupus nephritis and renal transplant indications.
Mycophenolate is in Phase 2 development for lupus nephritis, with Phase 3 trials conducted in renal transplant. It is an investigational small molecule and is not described as FDA approved in the available development record. All four listed trials are completed, with no active trials currently ongoing.
Four completed trials are registered for mycophenolate. NCT00423098 studied enteric-coated mycophenolate sodium with two corticosteroid regimens in lupus nephritis. NCT00149903 compared it with mycophenolate mofetil in de novo renal transplant patients. NCT00149929 and NCT00149916 were renal transplant safety follow-up studies.
Mycophenolate is also known as mycophenolate sodium, including the enteric-coated formulation. The enteric-coated mycophenolate sodium form is the version studied in the registered trials for lupus nephritis and renal transplant, so searches for either name refer to the same drug asset.