se of Desidustat or darbepoetin to cure low blood in patients with kidney disease

Phase 4

• Conditions: Health Condition 1: N189- Chronic kidney disease, unspecified

• Registration Number: CTRI/2023/11/059727
• Lead Sponsor: Saajid Hameed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations was to be 7.0-10.0 g/dL (both inclusive) before the enrollment.

2.Ability to understand and give informed consent for participation.

3.Male or female patients diagnosed with CKD (stage III to IV), defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.

4.Male or female, 18 to 80 years of age.

5.Body weight > 40 kg.

6.Subjects not on dialysis and not expected to start dialysis during the study period.

7.Serum ferritin =100 ng/mL and/or TSAT >20%.

8.No iron, folate or Vitamin B12 deficiency.

Exclusion Criteria

Prior chronic hemodialysis or chronic peritoneal dialysis treatment.

Intravenous iron within 14 days prior to enrollment.

Prior exposure of rhEPO analogues less than 04 weeks.

Red blood cell transfusion within 8 weeks prior to enrollment.

History of previous or concurrent cancer.

Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus infection.

Active infection prior to enrollment.

History of renal transplant.

Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.

Presence or a history of bleeding disorders or clinical conditions that could increase risk of life-threatening bleeding.

Pregnant and breastfeeding women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified