Health Condition 1: I501- Left ventricular failure, unspecified
Conditions
Interventions
Intervention1: DESIDUSTAT 50mg/OD: Desidustat, an oral HIF-PHI developed by Cadila Healthcare Ltd. for the treatment of anemia due to
CKD, was found to be well-tolerated in single and multiple doses u
Sponsors
SRM COLLEGE OF PHARMACY
Eligibility
Inclusion criteria
Inclusion criteria: •Patient of both genders aged between 35-65yr •Patients who have a known history of Acute/Chronic Renal failure(Non Dialysis dependent) •Patients with a known history or newly diagnosed with any cardiovascular events (Heart failure ,atherosclerosis,MI,) •Patients with mildly reduced left ventricular ejection fraction(upto 40%) • Patients with baseline hemoglobin of 8-11g/dl •Patients willing to sign the Informed Consent Form
Exclusion criteria
Exclusion criteria: Patients who are on erythropoietin stimulating agents therapy (Epoetin and Darbepoetin) prior to enrollment in the study. Patients with a history of red blood cell transfusion prior to enrollment Patients with e GFR Pregnant and lactating women History of Autoimmune hemolytic anemia, Idiopathic Thrombocytopenic Purpura (ITP) or Thalassemia. Patients with any GI/small intestine related mal absorption syndromes History of Stroke or intracranial haemorrhage History of hepatic impairment Patients with symptoms of hypotension or a systolic blood pressure of less than 95 mm Hg Patients who are not ready for regular follow ups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effects of Desidustat (Group A) & Dapagliflozin (Group B) in improving parameters from complete blood picture (hemoglobin) at baseline & followup visits. To estimate the levels of serum hepcidin before & after the start of the both drug therapies and evaluate whether hepcidin levels are lowered as a result of drug therapies. To evaluate the cardiac parameters like ejection fraction from 2D ECHO and B-type natriuretic peptide (BNP) levels at baseline and subsequent visits. To assess the renal function tests like blood urea nitrogen (BUN), serum creatinine, eGFR, urine albumin-creatinine ratio (uACR) at baseline and follow up visits. To determine the changes in serum erythropoietin levels and serum ferritin levels at baseline and subsequent visits and also monitor fasting blood sugar, lipid profile, serum electrolytes and blood pressure at baseline during each follow up.Timepoint: Follow up will be done for every 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor & report any serious adverse drug reactions (SAEs) to Pharmacovigilance Programme of IndiaTimepoint: Follow up for every 4 months | — |
Countries
India
Contacts
Public ContactDr S Sarumathy
SRM College of Pharmacy
Outcome results
None listed