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

Phase 4

Not yet recruiting

• Conditions: Chronic kidney disease, unspecified,

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

Brief Summary

Our plan is to conduct a randomized trial to assess and verify the results of phase 3 trial whether desidustat has efficacy similar to darbepoetin and whether it has acceptable risk-benefit ratio regarding its safety and tolerability. The result of this study will generate more evidence for the clinician to use this drug in pharmacotherapy of anemia due to CKD. The study result will add to current limited evidence of newly approved drug desidustat for its efficacy and safety for its use in anemia due to CKD. If acceptable risk-benefit ratio is proven, this drug can also be utilized in other causes of anemia where there is role of hepcidin in the pathophysiology of the anemia.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-10-29
• Study Start: 2023-11-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

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

Primary Outcome Measures

Name	Time	Method
Mean change in hemoglobin	0 to 6 months

Secondary Outcome Measures

Name	Time	Method
Time to achieve target range hemoglobin level of 10–12 g/dL	Not Applicable
Percentage of time spent in the target hemoglobin range (10-12 g/dl)	0 to 6 months
Number of subjects with hemoglobin response defined as target level of 10–12 g/dL and post-treatment increase of 1 g/dL or more by Week 24	0 to 6 months
Change in blood cells count	0 to 6 months
Change in transferrin saturation	0 to 6 months
Change in the lipid, and lipoprotein profile	0 to 6 months
Change in potassium levels	0 to 6 months
Number (%) of subjects on rescue therapy	0 to 6 months
Change in Packed Cell Volume (PCV)	0 to 6 months
Change in erythrocyte sedimentation rate (ESR) and C- Reactive Protein (CRP)	0 to 6 months

Trial Locations

Locations (1)

Indira Gandhi Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

Indira Gandhi Institute of Medical Sciences

🇮🇳Patna, BIHAR, India

Dr Saajid Hameed

Principal investigator

7739929293

saajid36@gmail.com