Study for evaluate the safety and efficacy of Darbotin in the patient of anemia in chronic Kidney Disease.

Prospective analysis of safety and efficacy of Darbotin™ in observational post marketing surveillance for management of anemia in chronic kidney disease - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/10/058941

Enrollment

2800

Registered

2023-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: D631- Anemia in chronic kidney disease

Interventions

Intervention1: Darbotin 25 (Darbepoetin alfa 25 mcg) Darbotin 40 (Darbepoetin alfa 40 mcg) Darbotin 60 (Darbepoetin alfa 60 mcg) : Dose:0.45 mcg/kg body weight once weekly. Route of administration i

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult patient (age 18-75 years) of any gender 2. Patients newly prescribed with Darbotin™ for anemia in chronic kidney disease 3. Patient willing to comply with the protocol and written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients who do not meet requirement as per prescribing information of Darbotin™ 2. Pregnant and lactating females

Design outcomes

Primary

Measure	Time frame
Safety of Darbotin™ 1.Incidence of adverse event 2. Incidence of serious adverse eventTimepoint: at Day 90±7	—

Secondary

Measure	Time frame
Effectiveness: rise in Hemoglobin (Hb) levels from baseline recordedTimepoint: at Day 90±7	—

Countries

India

Contacts

Public ContactDr Kokhan Debnath

Wockhardt Ltd

purushothamVS@wockhardt.com09739270420

Outcome results

None listed

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