]>
IRCT20260617069855N1 IRCT 2026-06-26 PEMH,Rawalpindi Comparison of Oral and Intravenous Iron Therapy for the Treatment of Anemia in Patients with End-Stage Renal Disease OIVI-ESRD Oral versus Intravenous Iron Therapy in the Treatment of Anemia among Patients with End-Stage Renal Disease: An Open-Label Randomized Controlled Trial at Pakistan Emirates Military Hospital, Rawalpindi, Pakistan 2024-09-01 anticipated 250 Complete https://irct.ir/trial/91115 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Prospective, single-center, open-label, parallel-arm randomized controlled trial with two intervention groups (oral iron versus intravenous iron) and 12-week follow-up. Outcome assessment includes hematological response, iron status parameters, and treatment-related adverse events, Randomization description: Participants will be randomized using a computer-generated randomization sequence. 93 in the intravenous group and 69 in the oral group. Allocation Concealment Sequentially numbered opaque sealed envelopes. N/A Anemia in patients with End-Stage Renal Disease (ESRD). Intervention 1: Intervention group: Participants will receive intravenous iron therapy with iron sucrose (Venofor) 200 mg administered intravenously once weekly for 5 consecutive weeks (total cumulative dose: 1000 mg), in addition to standard care for end-stage renal disease. Intervention 2: Control group: Participants will receive oral ferrous sulfate 200 mg once daily for 3 months, in addition to standard care for end-stage renal disease. Yes - There is a plan to make this available What will be shared: De-identified individual participant data underlying the published results, including baseline demographic characteristics, laboratory parameters (hemoglobin, serum ferritin, transferrin saturation), intervention allocation, and outcome measures. When: Beginning 6 months after publication of the primary study results and remaining available for 5 years To whom: Qualified researchers conducting scientifically sound research, subject to approval by the Principal Investigator and the Institutional Ethics Committee Conditions: To verify published results, perform secondary analyses, and conduct systematic reviews or meta-analyses. Where to obtain: Data will be shared upon reasonable request to the principal investigator after execution of a data-sharing agreement and approval by the institutional ethics committee. How to obtain: Data will be shared upon reasonable request to the principal investigator after execution of a data-sharing agreement and approval by the institutional ethics committee. Comments:
public Muhammad Sulman
HOUSE NO 07 , Street 64, SECTOR F , DHA PHASE 5,
Rawalpindi Pakistan 46000 +92 343 4491329 salmanzahoor964@gmail.com PEMH,Rawalpindi scientific Muhammad Sulman
Rawalpindi
Rawalpindi Pakistan 46000 +92 343 4491329 salmanzahoor964@gmail.com PEMH,Rawalpindi Pakistan Age 18 years or older. Diagnosed End-Stage Renal Disease. Diagnosed End-Stage Renal Disease anemia requiring iron supplementation according to treating nephrologist Ability and willingness to provide written informed consent. 18 years 65 years Both Active bleeding Blood transfusion within the preceding four weeks Known iron overload disorder Known hypersensitivity to oral or intravenous iron preparations. Pregnancy or lactation. Active systemic infection D63.1 Anemia in chronic kidney disease Treatment - Drugs Treatment - Drugs Intervention group: Participants will receive intravenous iron therapy with iron sucrose (Venofor) 200 mg administered intravenously once weekly for 5 consecutive weeks (total cumulative dose: 1000 mg), in addition to standard care for end-stage renal disease. Control group: Participants will receive oral ferrous sulfate 200 mg once daily for 3 months, in addition to standard care for end-stage renal disease. Change in hemoglobin concentration (g/dL) from baseline following iron therapy. Timepoint: Baseline and 12 weeks (3 months) after initiation of treatment. Method of measurement: Hemoglobin concentration (g/dL) will be measured using an automated hematology analyzer as part of routine laboratory investigations. The primary outcome will be calculated as the difference between baseline and 12-week hemoglobin values and compared between the oral iron and intravenous iron groups. Change in serum ferritin concentration (ng/mL). Timepoint: Baseline and 12 weeks (3 months) after initiation of treatment. Method of measurement: Serum ferritin will be measured using a validated immunoassay in the hospital laboratory. The change from baseline to 12 weeks will be compared between treatment groups. Change in transferrin saturation (TSAT, %). Timepoint: Baseline and 12 weeks (3 months) after initiation of treatment. Method of measurement: TSAT (%) will be calculated using the formula TSAT) = (Serum Iron ÷ Total Iron-Binding Capacity) × 100. Serum iron and TIBC will be measured using standard biochemical assays, and the change from baseline will be compared between groups. Requirement for erythropoiesis-stimulating agents (ESA). Timepoint: Baseline and 12 weeks (3 months) after initiation of treatment. Method of measurement: The proportion of participants requiring ESA therapy and the cumulative ESA dose administered during follow-up will be recorded from medical records. Requirement for blood transfusion. Timepoint: Throughout the 12-week follow-up period. Method of measurement: The number of participants requiring blood transfusion and the number of units transfused will be obtained from hospital records. PEMH,Rawalpindi Approved 2023-09-01 PEMH,Rawalpindi ,Pakistan abid majeed road Rawalpindi punjab Pakistan