An open-label, randomized, multicenter, parallel group study to demonstrate correction of anemia using intravenous injections of RO0503821 in patients with chronic kidney disease who are on dialysis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001298-24-ES

Enrollment

168

Registered

2004-06-28

Start date

2004-07-01

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anemia in chronic kidney patients who are in dialysis

Interventions

Product Name: cera Product Code: RO 0503821 Pharmaceutical Form: Solution for injection INN or Proposed INN: not yet available Other descriptive name: Methoxy polyethilene glycol-epoetin beta Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Baseline predialysis (for HD patients) Hb concentration 8-11 g/dL determined from the mean of 2 screening values with at least one day between measurements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Previous therapy with recombinant human erythropoetin or any other erythropoeitc substance within 12 weeks prior to screening. If epoetin treatment has been interrupted for at least 12 weeks, the patient may be enrolled in the study. Ongoing epoetin treatment should not be discontinued to allow participation in the trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the efficay of IV RO 0503821;Secondary Objective: - To asses time to response - To asses the safety and tolerability of multiple doses of RO 0503821 during the correction and extension periods in this patient population - To asses long term safety with RO 0503821 in this patient population - To investigate the farmachokinetics and the concentration-effect relationships after IV administration of RO 0503821 in this patient population;Primary end point(s): To demonstrate the efficay of IV RO 0503821 treatment for correction of anemia in patients with kidney chronic disease who are on dialysis	—

Measure

Time frame

Main Objective: To demonstrate the efficay of IV RO 0503821;Secondary Objective: - To asses time to response - To asses the safety and tolerability of multiple doses of RO 0503821 during the correction and extension periods in this patient population - To asses long term safety with RO 0503821 in this patient population - To investigate the farmachokinetics and the concentration-effect relationships after IV administration of RO 0503821 in this patient population;Primary end point(s): To demonstrate the efficay of IV RO 0503821 treatment for correction of anemia in patients with kidney chronic disease who are on dialysis

—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026