Health Condition 1: N186- End stage renal disease
Conditions
Interventions
Intervention1: ORAL DESIDUSTAT TABLET: Desidustat, an oral HIF-PHI(hypoxia inducible factor-prolyl hydroxylase inhibitor) for the treatment of anemia due to CKD.
The initial dose of desidustat will
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1)Ability to understand and given informed consent for participation 2)Male or female patients diagnosed with CKD Stage V 3)Aged =18 years at screening visit. 4)Patients on hemodialysis (=2 times in a week) for at least 12 weeks prior to screening visit and had access consisting of an arteriovenous fistula, AV graft, or permanent catheter). 5)Patients with no planned change in dialysis modality and with no planned renal transplant during study period
Exclusion criteria
Exclusion criteria: 1)Red blood cell transfusion within 8 weeks prior to participating in the study. 2)Had history of previous or concurrent cancer. 3)Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection. 4)Active infection at initiation of study. 5)Had history of renal transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin level :Change in Hb levels from baselineTimepoint: 16 week time period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Hemoglobin Response :No. of subjects with Hb response 2)Hemoglobin target range :Time to achieve target range Hb level Timepoint: 16 week time | — |
Countries
India
Contacts
Public ContactDR RITESH RAMESH VERNEKAR
Jawaharlal Nehru Medical College belagavi
Outcome results
None listed