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
Department of Nephrology, Pakistan Emirates Military Hospital (PEMH), Rawalpindi, Pakistan.
Participants/Inclusion and exclusion criteria
Age 18 years or older.
Diagnosed End-Stage Renal Disease.
Anemia requiring iron supplementation, according to the treating nephrologist.
Ability and willingness to provide written informed consent.
Exclusion Criteria
Active bleeding.
Blood transfusion within the preceding four weeks.
Known iron overload disorder.
Active systemic infection.
Known hypersensitivity to oral or intravenous iron preparations.
Pregnancy or lactation.
Active malignancy.
Intervention groups
IntraDrug Name: Iron Sucrose (Venofor®)
Dosage and Administration:
200 mg intravenous infusion once weekly
Five consecutive doses
Total cumulative dose: 1000 mgvenous Iron Therapy
Main outcome variables
Change in hemoglobin concentration (g/dL) from baseline to 12 weeks after initiation of treatment.
General information
Reason for update
Acronym
OIVI-ESRD
IRCT registration information
IRCT registration number:IRCT20260617069855N1
Registration date:2026-06-26, 1405/04/05
Registration timing:retrospective
Last update:2026-06-26, 1405/04/05
Update count:0
Registration date
2026-06-26, 1405/04/05
Registrant information
Name
muhammad sulman
Name of organization / entity
National university of medical sciences, rawalpindi
Country
Pakistan
Phone
+92 343 4491329
Email address
salmanzahoor964@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-01, 1403/06/11
Expected recruitment end date
2025-09-01, 1404/06/10
Actual recruitment start date
2024-09-15, 1403/06/25
Actual recruitment end date
2025-10-30, 1404/08/08
Trial completion date
2026-01-31, 1404/11/11
Scientific title
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
Public title
Comparison of Oral and Intravenous Iron Therapy for the Treatment of Anemia in Patients with End-Stage Renal Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
250
Actual sample size reached:
163
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
PEMH,Rawalpindi ,Pakistan
Street address
abid majeed road
City
Rawalpindi
Postal code
46000
Approval date
2023-09-01, 1402/06/10
Ethics committee reference number
ERC/552/23
Health conditions studied
1
Description of health condition studied
Anemia in patients with End-Stage Renal Disease (ESRD)
ICD-10 code
D63.1
ICD-10 code description
Anemia in chronic kidney disease
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
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.
2
Description
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.
3
Description
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.
4
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
PEMH,Rawalpindi
Full name of responsible person
Muhammad Sulman
Street address
HOUSE NO 07 , Street 64, SECTOR F , DHA PHASE 5,
City
Rawalpindi
Postal code
46000
Phone
+92 343 4491329
Email
salmanzahoor964@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
PEMH,Rawalpindi
Full name of responsible person
Muhammad Sulman
Street address
Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 343 4491329
Email
shaffaqzaman@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
PEMH,Rawalpindi
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
PEMH,Rawalpindi
Full name of responsible person
Muhammad Sulman
Position
internal medicine registrar
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
HOUSE NO 07 , Street 64, SECTOR F , DHA PHASE 5,
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 343 4491329
Email
salmanzahoor964@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
PEMH,Rawalpindi
Full name of responsible person
Muhammad Sulman
Position
Internal Medicine Registrar
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 343 4491329
Email
salmanzahoor964@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Pemh , rawalpindi
Full name of responsible person
Shafaq Zaman
Position
consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 321 6822201
Email
shaffaqzaman@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
Beginning 6 months after publication of the primary study results and remaining available for 5 years
To whom data/document is available
Qualified researchers conducting scientifically sound research, subject to approval by the Principal Investigator and the Institutional Ethics Committee
Under which criteria data/document could be used
To verify published results, perform secondary analyses, and conduct systematic reviews or meta-analyses.
From where data/document is obtainable
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.
What processes are involved for a request to access data/document
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.