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A study to improve anemia treatment in kidney patients on dialysis by adjusting erythropoietin and iron doses with the help of a clinical pharmacist.

Development and testing of an algorithm by a clinical pharmacist for optimization of erythropoietin and iron dosing for correcting anemia in patients undergoing hemodialysis (Proof of Concept): An Interventional Study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094517
Enrollment
55
Registered
2025-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: D631- Anemia in chronic kidney disease

Interventions

Intervention1: Clinical pharmacist managed dosing of erythropoietin and iron sucrose: Patients undergoing hemodialysis will receive erythropoietin and iron sucrose according to a pharmacist-managed do

Sponsors

KLE College of Pharmacy Belagavi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults equal to and above 18 years of age. 2.Patients with Chronic Kidney Disease (CKD) on maintenance hemodialysis. 3.Patients diagnosed with anemia and receiving erythropoietin therapy (with or without iron supplementation). 4.Clinically stable patients able to comply with study procedures. 5.Patients who provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women. 2.Patients with active bleeding disorders or recent (within 3 months) major blood transfusion. 3.Patients with uncontrolled hypertension or severe cardiovascular instability. 4.Patients with active infection, malignancy, or other comorbidities likely to interfere with anaemia management. 5.Patients with known hypersensitivity to erythropoietin or iron preparations.

Design outcomes

Primary

MeasureTime frame
To develop and test a clinical pharmacist?managed dosing algorithm for optimizing erythropoietin and iron therapy to correct and maintain hemoglobin within the target range (10?11.5 g/dL) in patients undergoing hemodialysis.Timepoint: Baseline (pre-intervention) and monthly follow-ups for 6 months.

Secondary

MeasureTime frame
To evaluate the effect of the pharmacist-managed algorithm on erythropoietin dose requirements compared with baseline prescribing.Timepoint: Baseline, monthly follow-ups, and final assessment at 6 months.;To assess changes in iron parameters (serum ferritin, transferrin saturation) following algorithm-based interventions.Timepoint: Baseline, monthly follow-ups, and final assessment at 6 months.;To determine the proportion of patients requiring red blood cell transfusions before and after algorithm implementation.Timepoint: Baseline, monthly follow-ups, and final assessment at 6 months.;To assess the safety of the algorithm by monitoring adverse drug reactions, iron overload, and rapid hemoglobin rises.Timepoint: Baseline, monthly follow-ups, and final assessment at 6 months.;To evaluate the acceptance rate of pharmacist recommendations by nephrologists.Timepoint: Baseline, monthly follow-ups, and final assessment at 6 months.;To assess the feasibility of implementing the dosing algorithm in a hemodialysis setting (recruitment rate, retention, time per patient review).Timepoint: Baseline, monthly follow-ups, and final assessment at 6 months.

Countries

India

Contacts

Public ContactDr Geetanjali S Salimath

KLE College of Pharmacy Belagavi

geetanjalisalimath@klepharm.edu9902687176

Outcome results

None listed

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