Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mycophenolate · 6 trials · 3 indications
The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason.
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 |
|---|---|---|
| Immediate Everolimus (IE) | ACTIVE_COMPARATOR | Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months. |
| Delayed Everolimus | EXPERIMENTAL | The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months. |
| 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 |
|---|---|---|
| Everolimus | DRUG | Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally. |
| Mycophenolate sodium | DRUG | Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating. |
| Cyclosporine | DRUG | Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally. |
| Steroids | DRUG | Steroids were administered according to local clinical practice. |
| Mycophenolate sodium (enteric coated) | DRUG | - |
| 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. |
Key Inclusion criteria: * Patients who are willing and able to participate in the study and who provide written informed consent before performing any study related procedure; * Men or women ≥18 years at transplant; * Recipients of 1st or 2nd single kidney transplant from deceased donor or living u...
Mycophenolate is an investigational small molecule being developed for renal transplant, kidney transplantation, and lupus nephritis. It is studied as an enteric-coated mycophenolate sodium formulation in clinical trials. The drug is not approved and remains in clinical development.
Mycophenolate is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials of the drug in renal transplant and lupus nephritis indications.
Mycophenolate is in Phase 3 clinical development for renal transplant, based on completed Phase 3 trials. It has also been studied in a Phase 2 trial for lupus nephritis. The drug is investigational and not yet approved.
Mycophenolate has been studied in four completed trials, including NCT00149903, NCT00149916, NCT00149929, and NCT00423098. These trials evaluated enteric-coated mycophenolate sodium in renal transplant patients and in lupus nephritis flare treatment.
Mycophenolate refers to the drug studied in clinical trials as enteric-coated mycophenolate sodium. The trials listed under Mycophenolate specifically test this formulation, distinguishing it from other mycophenolate salts.