Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mycophenolate Mofetil · 10 trials · 11 indications
Cmax was expressed in milligrams per liter (mg/L).
Cmax was expressed in mg/L.
Cmax was expressed in mg/L.
Cmax was expressed in mg/L.
Cmax was expressed in micrograms per liter (mcg/L).
Cmax was expressed in mcg/L.
Cmax was expressed in mcg/L.
Cmax was expressed in mcg/L.
Dose-normalized Cmax was determined (in 1 per liter \[1/L\]) by dividing the Cmax by the actual dose taken.
Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.
Cmin was expressed in mg/L.
Cmin was expressed in mg/L.
Cmin was expressed in mg/L.
Cmin was expressed in mg/L.
Cmin was expressed in mcg/L.
Cmin was expressed in mcg/L.
Cmin was expressed in mcg/L.
Cmin was expressed in mcg/L.
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in liters per hour (L/hour).
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours\*\[mg/L\]).
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mg/L).
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mg/L).
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mg/L).
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours\*\[mcg/L\]).
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mcg/L).
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mcg/L).
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours\*(mcg/L).
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.
MPA Free fraction (in percent \[%\]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.
Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis.
BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10 percent (%) compared to baseline (BL) values and BPAR of Grade greater than or equal to (≥) 1 according to Banff 1997 classification at Week 12.
International Working Group (IWG) criteria for hematological improvement was defined as having hemoglobin (Hgb) \<11 g/dL (pretreatment) and an increase in Hgb ≥1.5 g/dL after ≥8 weeks of treatment.
Diagnosis of acute rejection was suspected in any participant with an increase in serum creatinine greater than or equal to (≥) 25 percent (%). All suspected acute rejections were confirmed by biopsy. The start date of acute rejection was identified as the date of biopsy.
The mean time, in days, from the date of enrollment to date of biopsy confirming acute rejection.
BPAR was defined according to 1997 Banff Criteria as a biopsy Banff grade of IA, IB, IIA, IIB, or III. Grade IA was defined as significant interstitial infiltration with greater than (\>)25% of parenchyma affected, and foci of moderate tubulitis with \>4 mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IB was defined as significant interstitial infiltration with \>25% parenchyma affected, and foci of severe tubulitis with \>10% mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IIA was defined as mild to moderate intimal arteritis. Grade IIB was defined as severe intimal arteritis comprising \>25% of the luminal area. Grade III was defined as transmural arteritis and/or arterial fibrinoid changes and necrosis of medial smooth muscle cells.
| Arm | Type | Description |
|---|---|---|
| Mycophenolate Mofetil (MMF) | ACTIVE_COMPARATOR | Participants will receive MMF orally twice daily (every 12 hours, Q12H) from Day 1 to Week 52. Participants will also receive rituximab matching placebo by intravenous (IV) infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria have been met. |
| Rituximab (RTX) | EXPERIMENTAL | Participants will receive rituximab by IV infusion on Days 1 and 15 with repeat administration on Days 168 and 182 provided specific safety criteria have been met. Participants will also receive MMF matching placebo orally twice daily Q12H from Day 1 to Week 52. |
| Mycophenolate Mofetil; Cystic Fibrosis | EXPERIMENTAL | Participants with cystic fibrosis will receive mycophenolate mofetil 1.5 g, orally (PO), BID from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation. |
| Mycophenolate Mofetil; Other | EXPERIMENTAL | Participants with COPD, emphysema, idiopathic pulmonary fibrosis, or A1AD will receive mycophenolate mofetil 1.5 g, PO, BID, from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation. |
| MMF, CsA, Corticosteroids | EXPERIMENTAL | Participants received mycophenolate mofetil (MMF) 1.0 grams (g), orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of cyclosporine A (CsA) 4 to 6 milligrams per kilogram (mg/kg) within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center. |
| Mycophenolate Mofetil, Adapted Dose | EXPERIMENTAL | Participants received 3 grams (g) mycophenolate mofetil (MMF) tablets per os (p.o.) in divided doses (every 12 hours \[q12h\]) adapted to mycophenolic acid (MPA) by area under the curve (AUC) beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing through Week 52. In addition, induction by interleukin-2R (IL-2R) was administered at Day 0 per standard of care at the site at the investigator's discretion. At 72 hours post-transplantation, participants received cyclosporine 100-1500 nanograms (ng) per (/) milliliter (mL) from Day 0 to (-) Week 4, 800-1200 ng/mL from Week 4 - Week 12 and 500-800 ng/mL from Week 12 - Week 52. Solumedrol 500 mg intravenously (i.v.) was administered before or after the transplantation, and 0.5 milligrams (mg) per kilogram (kg) p.o. daily from Day 1 - Day 7. |
| Mycophenolate Mofetil, Fixed Dose | ACTIVE_COMPARATOR | Participants received 2 g MMF tablets p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing through Week 52. In addition, induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion. At 72 hours post-transplantation, participants received cyclosporine 100-1500 ng/mL from Day 0 - Week 4, 800-1200 ng/mL from Week 4 - Week 12 and 500-800 ng/mL from Week 12 - Week 52. Solumedrol 500 mg i.v. was administered before or after the transplantation, and 0.5 mg/kg p.o. daily from Day 1 - Day 7. |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Mycophenolate Mofetil + Prednisone + Erythropoietin Beta | EXPERIMENTAL | Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12. |
| Mycophenolate Mofetil Monotherapy | EXPERIMENTAL | Participants received an initial dose of mycophenolate mofetil (MMF), 1 gram (g), orally (PO), twice per day (BID), within 5 days of transplant for 24 weeks. Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice. |
| Name | Type | Description |
|---|---|---|
| Mycophenolate Mofetil Placebo | DRUG | MMF matching placebo will be administered orally Q12H. |
| Mycophenolate Mofetil | DRUG | MMF will be administered at a starting dose of 500 milligrams (mg) Q12H and the dose will be titrated to achieve a goal of 1 gram (gm) Q12H. |
| Rituximab | DRUG | Rituximab will be administered at a dose of 1000 mg via IV infusion. |
| Rituximab Placebo | DRUG | Rituximab matching placebo will be administered via IV infusion. |
| mycophenolate mofetil (MMF) | DRUG | 1.0 g PO BID |
| cyclosporine A (CsA) | DRUG | Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL |
| corticosteroids | DRUG | As per the practice of each participating center |
| anti-IL-2R | DRUG | Induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion. |
| methylprednisolone | DRUG | 500 mg intravenous (i.v.) was administered before or after the transplantation, and 0.5 mg/kg p.o. daily from Day 1 to Day 7. |
| cyclosporine | DRUG | 100-1500 nanograms (ng) per milliliter (mL) from Day 0 to Week 4, 800-1200 ng/mL from Week 4 to Week 12 and 500-800 ng/mL from Week 12 to Week 52 |
| mycophenolate mofetil (CellCept) | DRUG | 1g bid for 36 weeks |
| placebo | DRUG | po bid for 36 weeks |
| mycophenolate mofetil [CellCept] | DRUG | 1g po bid |
| Prednisone | DRUG | 10 mg/day orally until end of study. |
| Erythropoietin Beta | DRUG | Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks. |
| antibody induction | DRUG | According to manufacturer recommendation |
| corticosteroid | DRUG | According to manufacturer recommendation |
Inclusion Criteria: * Confirmed diagnosis of PV within the previous 24 months, based on the presence of histological features of acantholysis via skin or mucosal biopsy and one of the following: tissue bound immunoglobulin G (IgG) antibodies by direct immunofluorescence on the surface of affected e...
Mycophenolate Mofetil is an immunosuppressant small molecule being studied for use in Pemphigus Vulgaris, Myelodysplastic Syndromes, Chronic Kidney Failure, Heart Transplantation, and Lung Transplantation. It is developed by Roche Holding AG (RHHBY) and is currently in Phase 3 clinical development for these indications.
Mycophenolate Mofetil is an immunosuppressant that inhibits inosine monophosphate dehydrogenase, an enzyme crucial for the de novo synthesis of guanine nucleotides in lymphocytes. By blocking this enzyme, it selectively suppresses T and B cell proliferation, reducing the immune response that contributes to autoimmune and transplant-related conditions.
Mycophenolate Mofetil is developed by Roche Holding AG, a Swiss multinational healthcare company traded on the OTC market under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's efficacy and safety in various conditions, including heart transplantation and myelodysplastic syndromes.
Mycophenolate Mofetil is in Phase 3 clinical development. It has completed three trials, including two Phase 3 studies and one Phase 2 study, with a total enrollment of 640 participants. The drug is investigational and not yet approved for the studied indications.
Mycophenolate Mofetil has been studied in three completed trials: NCT00282347 (Phase 3, Lupus Nephritis, 144 participants), NCT00551291 (Phase 2, Myelodysplastic Syndromes, 10 participants), and NCT02091414 (Phase 3, Heart Transplantation, 36 participants). All trials are completed with no active studies ongoing.
Yes, Mycophenolate Mofetil is the same as CellCept, a brand name used in clinical trials. In the study NCT00551291, the drug is referred to as CellCept, and in NCT02091414, it is also called CellCept. Both names refer to the same immunosuppressant compound developed by Roche.