Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RO0503821 · 1 trial · 1 indication
A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.
| Arm | Type | Description |
|---|---|---|
| RO0503821 (1x/2 Weeks) | EXPERIMENTAL | Participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram \[mcg\]) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 International units \[IU\]/Week) administered during the week preceding the switch to the study drug. |
| RO0503821 (1x/4 Weeks) | EXPERIMENTAL | Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (\<8000, 8000-16000, \>16000 IU/Week) administered during the week preceding the switch to the study drug. |
| Epoetin (1-3x/Weeks) | ACTIVE_COMPARATOR | Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks. |
| Name | Type | Description |
|---|---|---|
| Epoetin alfa or beta | DRUG | intravenously 3 times weekly for 52 weeks, as prescribed |
| RO0503821 (1x/2 Weeks) | DRUG | 60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks. |
| RO0503821 (1x/4 Weeks) | DRUG | 120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks. |
Inclusion Criteria: * adult patients \>=18 years of age; * chronic renal anemia; * on dialysis therapy for at least 12 weeks before screening; * receiving IV epoetin for at least 8 weeks before screening. Exclusion Criteria: * women who are pregnant, breastfeeding or using unreliable birth contro...
RO0503821 is an investigational small molecule being developed for the treatment of anemia. It is being studied in patients with anemia who are on dialysis. The drug is administered intravenously and is currently in Phase 3 clinical development.
RO0503821 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating anemia in dialysis patients.
RO0503821 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 study has been completed to assess its use in treating anemia in dialysis patients.
RO0503821 has one completed Phase 3 clinical trial, identified as NCT00077610. This study evaluated the intravenous administration of the drug for the treatment of anemia in dialysis patients and enrolled 673 participants across multiple countries.
RO0503821 is also known as Mircera. The completed Phase 3 trial, NCT00077610, was titled 'A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients,' confirming that Mircera is the brand name for RO0503821.