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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 Enteric-coated mycophenolate sodium (EC-MPS), Enteric-Coated Mycophenolate Sodium, Myfortic
Enteric-coated mycophenolate · 16 trials · 12 indications
Treatment failures defined as Biopsy Proven Acute Rejection (BPAR), graft loss, death or loss to follow-up. Only BPAR from other biopsies than the protocol defined biopsy at Month 3 are described. Acute rejection: an episode of acute renal dysfunction diagnosed as rejection on the basis of biopsy or clinical observations, treated with anti-rejection medication. BPAR: renal transplant biopsy finding of acute cellular or antibody mediated rejection. Graft loss: allograft will be presumed to be lost on the day the patient starts dialysis and is not able to subsequently be removed from dialysis.
Change in Gastrointestinal symptom rating scale (GSRS) total score from baseline visit to follow-up visit 6-8 weeks after treatment. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores.
Changes in GI symptom severity was measured by changes in the Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline visit to the visit at 6-8 weeks. This total score was calculated as the average of the 15 single items (each ranging from 1-7 score points) and thus also had a range from 1-7 score points. Higher values indicate more unfavorable conditions.
Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.
Median time to first occurrence of treatment failure was not reached in this study.
Treatment failures were defined as a composite endpoint of biopsy proven acute rejection (BPAR), graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months or until final assessment. Any participants who were suspected of having acute rejection episodes had biopsies performed to prove whether a rejection had occurred. Graft loss was considered as the day the patient started dialysis and was not able to subsequently be removed or the day of graft nephrectomy.
Change in estimated glomerular filtration rate from baseline to Month 6 calculated by using abbreviated Modification of Diet in Renal Disease (MDRD) formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R where -C is the serum concentration of creatinine \[mg/dL\], -A is patient age at sample collection date \[years\], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.
The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation,abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores. The primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.
| Arm | Type | Description |
|---|---|---|
| Without Steroids | EXPERIMENTAL | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study. |
| With Steroids | ACTIVE_COMPARATOR | Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone. |
| Enteric-coated Mycophenolate sodium | EXPERIMENTAL | Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg. |
| Intensified Mycophenolate sodium | EXPERIMENTAL | Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 180 days. |
| Standard Mycophenolate sodium | ACTIVE_COMPARATOR | Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg). Total duration of treatment was 6 months. |
| Standard dose EC-MPS | ACTIVE_COMPARATOR | Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) adjusted to maintain the trough blood level (C0) contained between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day. |
| High EC-MPS | EXPERIMENTAL | Patients received 1440 mg/day (720 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) tapered to reach a trough blood level target contained between 2 and 4.5 ng/mL within 15 days after randomization at the most. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day. |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Enteric-coated mycophenolate sodium (EC-MPS) | DRUG | An initial dose of 1080 mg EC-MPS was administered immediately before transplantation. Then, during the first 6 weeks post-transplantation, EC-MPS was administered at a dose of 1080 mg twice a day 12 hours apart. From week 7 until the end of the study (month 6), EC-MPS was administered at standard dose of 720 mg twice a day. |
| Prednisone | DRUG | Oral tablets |
| Enteric-coated Mycophenolate Sodium | DRUG | Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily. |
| Tacrolimus | DRUG | - |
| Corticosteroids | DRUG | At a dose of at least 5 mg/day. |
| Myfortic | DRUG | - |
| Enteric-coated Mycophenolate sodium (EC-MPS), valsartan | DRUG | - |
Inclusion Criteria: * Primary donor kidney transplant * Panel reactive antibody (PRA) ≤ 20% Exclusion Criteria: * Multi-organ transplantation including dual kidneys or previous transplant with any other organ different from kidney * Non-heart beating donor or kidney from a non-compatible donor O...
Enteric-coated mycophenolate is an oral small-molecule immunosuppressant developed by Novartis AG. It is studied in immunology for autoimmune disease and for kidney and liver transplant recipients, including de novo renal transplantation. The enteric coating is designed to release the drug in the intestine rather than the stomach.
Enteric-coated mycophenolate is used to prevent organ rejection in kidney transplant recipients and is also studied in liver transplant recipients and in patients with autoimmune diseases. Its Phase 3 trials enrolled adults receiving the drug alongside cyclosporine, with or without corticosteroids, after renal transplantation.
Enteric-coated mycophenolate is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 3 studies of the drug in renal transplantation, liver transplantation, and autoimmune disease conducted in France and Germany.
Enteric-coated mycophenolate is in Phase 3 development. Four Phase 3 trials have been completed, with no active trials currently listed, and total enrollment across those completed studies was 474 adult participants. The program covers renal transplantation, liver transplantation, and autoimmune disease.
Completed Phase 3 trials include NCT00413920 in renal transplantation in France with 222 participants, NCT00369278 comparing intensified and standard dosing in de novo renal transplant patients in Germany with 128 participants, NCT00405652 in liver transplant recipients in Germany with 34 participants, and NCT00351377 in autoimmune disease in Germany with 111 participants.
Yes. Enteric-coated mycophenolate is also known as enteric-coated mycophenolate sodium, or EC-MPS. Those names refer to the same enteric-coated sodium salt formulation developed by Novartis AG, so searches for EC-MPS, enteric-coated mycophenolate sodium, or enteric coated mycophenolate all point to this same drug.