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A study to assess the effect of desidustat in comparison to erythropoietin in patients of anemia with chronic kidney disease.

Randomized controlled trial to compare the safety and efficacy of desidustat with erythropoietin in adult patient suffering from anemia in chronic kidney disease. - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062658
Enrollment
90
Registered
2024-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Desidustat: Tab desidustat 50 mg orally three times a week with maximum dose increased Upto 150 mg three times a week depend on hemoglobin level. Control Intervention1: Erythropoietin:

Sponsors

Dr Sachin Sharma
Lead Sponsor
MultiDisciplinary Research Unit
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient willing to give written informed consent. 2.Age more than 18 years. 3.Male or female patient with current clinical diagnosis of anemia due to CKD having baseline hemoglobin concentrations

Exclusion criteria

Exclusion criteria: 1.Age less than 18 years. 2.Patients who received red blood cell transfusion within 8 weeks prior to enrollment. 3.Hematological malignancy or primary hematological disease. 4.Malignancy of any organ. 5.Presence or a history of bleeding disorder. 6.Serological status reflecting active hepatitis B or C or Human immunodeficiency virus (HIV) infection. 7.History of renal transplant. 8.Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestinal absorption such as mal absorption syndrome, resection of small bowel or poorly controlled inflammatory bowel disease affecting small intestine. 9.History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia. 10.Known hypersensitivity to investigational products or with known contraindications to any of the study drug. 11.Women who are trying to conceive, pregnant and breast-feeding women.

Design outcomes

Primary

MeasureTime frame
Mean change in hemoglobin.Timepoint: Baseline to 3 months

Secondary

MeasureTime frame
Change in hematological and biochemical parameters as mentioned in protocol annexure III) before and after receiving drug like Serum Hepcidin level, Vitamin D, Phosphate, Parathormone, Lipid Profile Timepoint: Baseline to 3 months

Countries

India

Contacts

Public ContactDr Abhinav Rana

Dr Rajendra Prasad Government Medical College Tanda HP

atalsood7@gmail.com9418063191

Outcome results

None listed

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