Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mircera · 2 trials · 2 indications
A time adjusted average baseline hemoglobin (Hb) concentration was calculated using the trapezoid rule from all available Hb measurements taken during the baseline period. The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the two month evaluation period. The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb from the evaluation period Hb. All blood samples for Hb measurements were taken prior to study drug administration.
The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive.
| Arm | Type | Description |
|---|---|---|
| Mircera | EXPERIMENTAL | Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera. |
| Darbepoetin alfa | ACTIVE_COMPARATOR | Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months). |
| Name | Type | Description |
|---|---|---|
| Mircera | DRUG | Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month. |
| Darbepoetin alfa | DRUG | As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications. |
Inclusion Criteria: * adult patients, \>=18 years of age; * chronic kidney disease, not requiring dialysis; * receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period. Exclusion Criteria: * overt gastrointestinal bleeding within 8 weeks ...
Mircera is used for the treatment of anemia, including anemia associated with chronic kidney disease. It is being studied in patients with chronic kidney disease who are on dialysis or not yet on dialysis. The drug is administered subcutaneously.
Mircera is developed by Roche Holding AG, a company traded under the ticker RHHBY. Roche is conducting clinical trials to evaluate the drug's use in treating anemia in patients with chronic kidney disease.
Mircera is in Phase 3 clinical development for the treatment of anemia. It has completed Phase 3 and Phase 2 trials, with two completed studies involving a total of 268 participants. The drug remains investigational and is not yet approved.
Mircera has been studied in two completed clinical trials. NCT00442702 was a Phase 3 study in adults with chronic kidney disease not on dialysis, enrolling 228 participants. NCT03552393 was a Phase 2 study in pediatric patients with chronic kidney disease, enrolling 40 participants.
Mircera is not FDA approved. It is an investigational drug currently in clinical development for anemia. The completed trials have evaluated its use in chronic kidney disease patients, but the drug has not received regulatory approval.