A RANDOMIZED PROSPECTIVE STUDY COMPARING DESIDUSTAT AND ERYTHROPOIETIN FOR THE TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS ON PERITONEAL DIALYSIS(CAPD).

 

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https://storage.unitedwebnetwork.com/files/1099/252d6014ea762f609a45f4b945fb7342.pdf
A RANDOMIZED PROSPECTIVE STUDY COMPARING DESIDUSTAT AND ERYTHROPOIETIN FOR THE TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS ON PERITONEAL DIALYSIS(CAPD).

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Dr Indranil
Ghosh
Dr Indranil Ghosh rajpro_5@yahoo.com Army Hospital (Research And Referral) Nephrology and Transplant New Delhi India *
Dr Pavitra Manu Dogra dodgemanu@gmail.com Army Hospital (Research And Referral) Nephrology and Transplant New Delhi India -
Dr Shreya Rathore rajpro_5@yahoo.com Army Hospital (Research And Referral) Nephrology and Transplant New Delhi India -
Dr Ravi Prakash rajpro_5@yahoo.com Army Hospital (Research And Referral) Nephrology and Transplant New Delhi India -
Dr Sreenivasa S rajpro_5@yahoo.com Army Hospital (Research And Referral) Nephrology and Transplant New Delhi India -
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Anemia in Peritoneal Dialysis (PD) patients is multifactorial, driven by reduced erythropoietin synthesis, inflammation, and iron dysregulation. Conventional erythropoiesis-stimulating agents (ESAs) correct anemia but are injectable and limited by fluctuating response and inflammation-mediated resistance. Desidustat (DESI), an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor (HIF-PHI), stimulates endogenous erythropoietin while enhancing iron mobilization and reducing inflammatory blockade. This study compared DESI with ESA over six months in PD patients.

This is a CTRI-registered, single-centre, open-label, active-controlled prospective study designed to evaluate the efficacy and safety of Desidustat Tablet versus Erythropoietin Injection for the treatment of anemia in patients with CKD on Peritoneal Dialysis (PD). All patients had been on peritoneal dialysis for at least 3 months prior to inclusion in the study. Eligible subjects were screened within 4 weeks prior to the start of the study, and informed consent was obtained from each participant before any study-related activity. Patients were enrolled according to predefined inclusion and exclusion criteria and randomized in a 1:1 ratio to receive either Desidustat Tablet or Erythropoietin Injection. Seventy-one PD patients were enrolled (ESA = 38, DESI = 33). The cohort comprised 57% males and 43% females, with a mean age of 50.9 ± 20.2 years. Hemoglobin (Hb), creatinine, reticulocyte count, hepcidin, and high-sensitivity C-reactive protein (hsCRP) were assessed at baseline and monthly for six months. Intra- and inter-group changes were analyzed using paired and unpaired t-tests (p < 0.05 = significant).

Hemoglobin: Both groups showed Hb improvement, but DESI achieved a greater and earlier rise (+2.21 g/dL; p = 0.01) versus ESA (+1.47 g/dL; p = 0.02).
Reticulocyte count: Increased significantly with DESI (+0.46 %, p = 0.03), indicating stronger marrow stimulation.
Hepcidin: DESI markedly reduced hepcidin (42.4 → 20.9 ng/mL), while ESA showed a mild increase (42.1 → 48.0 ng/mL), reflecting superior iron availability and reduced sequestration under DESI.
Inflammation: hsCRP declined notably with DESI (19.3 → 10.9 mg/L) but rose modestly with ESA (10.1 → 14.1 mg/L), suggesting anti-inflammatory advantage through HIF stabilization.
Creatinine: Remained stable in both groups, confirming renal safety.
No treatment discontinuations or major adverse events occurred.

Hb rise from baseline(p<0.05)

Change in reticulocyte Count from baseline

Change in Hepcidin from baseline (p<0.05)


Desidustat provided a more robust, sustained, and biologically balanced anemia correction than ESA in PD patients. Beyond hemoglobin rise, Desidustat showed clear superiority in iron regulation (hepcidin reduction) and inflammatory control (hsCRP decline)—both critical determinants of anemia responsiveness. Its oral route, favorable biomarker profile, and renal safety position Desidustat as a promising, next-generation alternative for anemia management in dialysis-dependent CKD. Further multicenter validation is warranted.

Kewords