60 Participants Needed

Oral Iron for Chronic Kidney Disease

(FeTCh-CKD Trial)

Recruiting at 1 trial location
SB
CT
Overseen ByChristopher Tapia, B.S.
Age: < 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had iron therapy or certain blood treatments in the last 3-4 months before joining.

What data supports the effectiveness of the drug Ferrous Sulfate for chronic kidney disease?

The research indicates that oral iron, like Ferrous Sulfate, is commonly used to treat iron deficiency anemia in chronic kidney disease patients. Although the study did not find a significant difference in kidney function decline between oral and intravenous iron, oral iron was associated with fewer serious adverse events compared to intravenous iron.12345

Is oral iron, like ferrous sulfate, safe for people with chronic kidney disease?

Oral iron treatments, such as ferrous sulfate, are generally considered safe for people with chronic kidney disease, but they can cause gastrointestinal issues like diarrhea and constipation. Serious adverse events were more common with intravenous iron treatments compared to oral ones.16789

How does the drug Ferrous Sulfate differ from other treatments for chronic kidney disease?

Ferrous Sulfate is an oral iron supplement used to treat iron deficiency anemia in chronic kidney disease, offering a non-invasive alternative to intravenous iron, which has been associated with a higher risk of serious adverse events like cardiovascular issues and infections.14101112

What is the purpose of this trial?

This trial tests iron pills in children with kidney disease and mild anemia. It aims to see if taking iron improves their muscle strength, activity levels, and eating habits. The study compares children taking iron pills to those who do not over a few months.

Research Team

OA

Oleh Akchurin, M.D.

Principal Investigator

Weill Cornell College of Medicine

Eligibility Criteria

This trial is for children aged 1-21 with chronic kidney disease and mild anemia, not on hemodialysis or expecting a transplant soon. They must have specific levels of kidney function, hemoglobin, transferrin saturation, and serum ferritin to join.

Inclusion Criteria

I am between 1 and 21 years old.
Your kidney function, measured by a formula using your height and blood test results, is too low.
Your hemoglobin level was 9.0 or higher at your last doctor's visit.
See 2 more

Exclusion Criteria

My kidney function is quickly getting worse, and I might need dialysis or a transplant soon.
Your blood ferritin level is less than 10 ng/mL.
You are pregnant or breastfeeding.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months

12 weeks
Routine clinic visits for blood tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Ferrous Sulfate
Trial Overview The study tests if taking oral iron (ferrous sulfate) helps improve muscle strength, physical activity, and eating behavior in these kids compared to those who don't get iron therapy over a period of three months.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Oral Iron therapyExperimental Treatment1 Intervention
Participant will receive oral iron therapy.
Group II: No oral iron therapyActive Control1 Intervention
Participant will not receive oral iron therapy for 3 months.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Children's Hospital of Philadelphia

Collaborator

Trials
749
Recruited
11,400,000+

Findings from Research

In a study involving 136 patients with stage 3 and 4 chronic kidney disease (CKD) and iron deficiency anemia (IDA), both oral ferrous sulfate and intravenous iron sucrose showed similar declines in kidney function over two years, indicating no significant difference in their effects on glomerular filtration rate (mGFR).
However, intravenous iron therapy was associated with a higher risk of serious adverse events, including cardiovascular issues and infections, compared to oral iron, suggesting that while both treatments are effective for IDA, intravenous iron may pose additional safety risks.
A randomized trial of intravenous and oral iron in chronic kidney disease.Agarwal, R., Kusek, JW., Pappas, MK.[2022]
In a 1-year study involving 308 patients with iron-deficient anemia and nondialysis-dependent chronic kidney disease, only 21.6% showed a significant increase in hemoglobin after 4 weeks of oral iron therapy.
Among those who did not respond initially, less than 30% showed improvement by week 52, suggesting that alternative anemia treatments should be considered earlier for better management of anemia in these patients.
Erythropoietic response to oral iron in patients with nondialysis-dependent chronic kidney disease in the FIND-CKD trial .Macdougall, IC., Bock, AH., Carrera, F., et al.[2018]
In a study of 12 weeks involving 12,969 adult patients starting hemodialysis, maintenance intravenous (IV) iron administration did not significantly improve the likelihood of achieving hemoglobin levels between 10-12 g/dL.
However, patients receiving maintenance IV iron had a 33% higher chance of reducing their erythropoietin stimulating agent (ESA) dose by more than 25% and a 27% lower risk of mortality compared to those receiving non-maintenance iron.
Intravenous iron administration strategies and anemia management in hemodialysis patients.Michels, WM., Jaar, BG., Ephraim, PL., et al.[2018]

References

A randomized trial of intravenous and oral iron in chronic kidney disease. [2022]
Erythropoietic response to oral iron in patients with nondialysis-dependent chronic kidney disease in the FIND-CKD trial . [2018]
Intravenous iron administration strategies and anemia management in hemodialysis patients. [2018]
The effects of oral iron supplementation on the progression of anemia and renal dysfunction in patients with chronic kidney disease. [2019]
Treatment of Iron Deficiency Anemia in CKD and End-Stage Kidney Disease. [2023]
Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial. [2023]
Effects of Ferric Citrate in Patients with Nondialysis-Dependent CKD and Iron Deficiency Anemia. [2018]
Oral administration of ferrous sulfate, but not of iron polymaltose or sodium iron ethylenediaminetetraacetic acid (NaFeEDTA), results in a substantial increase of non-transferrin-bound iron in healthy iron-adequate men. [2022]
Recent and Emerging Therapies for Iron Deficiency in Anemia of CKD: A Review. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Iron absorption after single pharmacological oral iron loading test in patients on chronic peritoneal dialysis and in healthy volunteers. [2020]
Association of oral iron replacement therapy with kidney failure and mortality in CKD patients. [2023]
The therapeutic equivalence of oral and intravenous iron in renal dialysis patients. [2013]
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