Oral Iron for Chronic Kidney Disease

(FeTCh-CKD Trial)

Recruiting at 1 trial location

Overseen By Christopher Tapia, B.S.

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must not be taking: Iron therapy, Erythropoietin

Disqualifiers: Hemodialysis, Pregnancy, Rapid kidney decline, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effects of oral iron therapy on children with chronic kidney disease (CKD) who have mild anemia, characterized by a lack of healthy red blood cells. Researchers seek to determine if iron supplements, specifically ferrous sulfate, improve muscle strength, physical activity, and eating behavior over three months. The trial includes two groups: one receiving the iron supplement and the other not. Children with CKD and low iron levels in their blood may be suitable candidates for this study. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for a broader patient population.

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 is the safety track record for Ferrous Sulfate?

Research has shown that ferrous sulfate, a type of oral iron treatment, is generally safe for treating anemia in people with chronic kidney disease (CKD). One study comparing different iron treatments found that oral iron is easy for patients to handle, with no major side effects reported. Another review suggested that iron therapy can even help lower the risk of heart problems in CKD patients. This is encouraging for those considering joining a trial, as ferrous sulfate is already a common treatment for anemia. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other treatments for chronic kidney disease, which often involve intravenous iron therapy, ferrous sulfate offers an oral approach. This method is less invasive and can be more convenient for patients, potentially improving adherence to the treatment regimen. Researchers are excited because ferrous sulfate may provide a simpler and more patient-friendly way to manage anemia associated with chronic kidney disease, without the need for frequent hospital visits for infusions.

What evidence suggests that oral iron therapy might be an effective treatment for chronic kidney disease?

Research shows that ferrous sulfate can help treat low iron levels in people with chronic kidney disease (CKD). Studies have found that taking iron orally, such as ferrous sulfate, is a common method to manage low iron in CKD patients. However, some research suggests that intravenous iron might be more effective at raising iron levels and improving blood health. While oral iron can help, it might not work the same for everyone. Overall, ferrous sulfate is a well-known treatment for low iron in CKD patients, and this trial will compare the effects of oral iron therapy with no oral iron therapy in participants. ^{1 2 6 7 8}

Who Is on the Research Team?

Oleh Akchurin, M.D.

Principal Investigator

Weill Cornell College of Medicine

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

My kidney function is quickly getting worse, and I might need dialysis or a transplant soon.

You are pregnant or breastfeeding.

Your blood ferritin level is less than 10 ng/mL.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Oral Iron therapy Experimental Treatment 1 Intervention

Participant will receive oral iron therapy.

Group II: No oral iron therapy Active Control 1 Intervention

Participant will not receive oral iron therapy for 3 months.

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+

Published Research Related to This Trial

A superpharmacologic dose of iron sulfate (260 mg elemental iron) taken on an empty stomach resulted in significant iron absorption in chronic peritoneal dialysis patients, with a 105% increase in serum iron levels at 2 hours.

While the increase in serum iron was lower in dialysis patients compared to healthy controls, none of the dialysis patients experienced gastrointestinal side effects, suggesting this method could be a safe and effective way to supplement iron in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iron absorption after single pharmacological oral iron loading test in patients on chronic peritoneal dialysis and in healthy volunteers. Bastani, B., Islam, S., Boroujerdi, N.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of intravenous and oral iron in chronic kidney disease. Agarwal, R., Kusek, JW., Pappas, MK.[2022]

Iron deficiency is a significant contributor to anemia in individuals with chronic kidney disease, and recent advancements in oral and intravenous iron therapies have improved treatment options, including better tolerated oral agents like ferric citrate and ferric maltol.

New intravenous iron therapies, such as ferric carboxymaltose, reduce the number of required infusions and the risk of serious allergic reactions, but they may pose risks for conditions like 6H syndrome, which involves multiple metabolic disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent and Emerging Therapies for Iron Deficiency in Anemia of CKD: A Review. Bazeley, JW., Wish, JB.[2022]

In a study of 49,943 US Veterans with chronic kidney disease, oral iron replacement therapy (IRT) did not reduce the risk of progressing to end-stage kidney disease (ESKD) and was linked to a higher risk of all-cause mortality overall.

However, in patients with anemia and hemoglobin levels below 10 g/dL, oral IRT was associated with significantly lower mortality, suggesting that its benefits may be limited to specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of oral iron replacement therapy with kidney failure and mortality in CKD patients. Paul, S., Shrestha, P., Sumida, K., et al.[2023]

In a study of 182 anemic patients with chronic kidney disease (CKD), oral iron supplementation prevented a decrease in hemoglobin levels over 12 months, while the control group experienced significant declines.

Oral iron was particularly effective in patients with lower kidney function (eGFR < 30 ml/min/1.73 m2) and did not negatively affect kidney function, with similar rates of adverse events in both the iron and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of oral iron supplementation on the progression of anemia and renal dysfunction in patients with chronic kidney disease. Kim, SM., Lee, CH., Oh, YK., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous iron administration strategies and anemia management in hemodialysis patients. Michels, WM., Jaar, BG., Ephraim, PL., et al.[2018]

Iron deficiency is a significant issue for individuals with chronic kidney disease, leading to anemia, and both oral and intravenous (i.v.) iron treatments are available to address this deficiency.

Recent studies suggest that more aggressive iron repletion in patients with chronic kidney disease who require kidney replacement therapy can improve anemia management and may positively impact serious health outcomes like cardiovascular disease and survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Iron Deficiency Anemia in CKD and End-Stage Kidney Disease. Gutiérrez, OM.[2023]

In a cross-over trial involving patients undergoing renal dialysis, both oral iron (ferrous sulfate) and intravenous iron (iron dextran) were found to be equally effective, with no significant differences in therapeutic outcomes or side effects.

Each treatment was administered for 26 weeks, and both forms provided the same amount of elemental iron (100 mg), indicating that patients can choose either method without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic equivalence of oral and intravenous iron in renal dialysis patients. Strickland, ID., Chaput de Saintonge, DM., Boulton, FE., et al.[2013]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 60 adults with moderate to severe chronic kidney disease (CKD), ferric citrate was found to significantly increase transferrin saturation (TSAT) and ferritin levels compared to ferrous sulfate over a 12-week period.

Both treatments had similar safety profiles, with no significant differences in adverse events, indicating that ferric citrate is a safe and effective alternative for treating iron deficiency in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial. Womack, R., Berru, F., Panwar, B., et al.[2023]

In a randomized double-blind trial involving 232 adults with nondialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anemia, oral ferric citrate significantly increased hemoglobin levels compared to placebo, with 52.1% of patients achieving a ≥1.0 g/dl increase in hemoglobin (P<0.001).

Ferric citrate was found to be safe, with similar rates of serious adverse events (12.0% for ferric citrate vs. 11.2% for placebo), although gastrointestinal issues like diarrhea and constipation were more common in the ferric citrate group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Ferric Citrate in Patients with Nondialysis-Dependent CKD and Iron Deficiency Anemia. Fishbane, S., Block, GA., Loram, L., et al.[2018]

Oral iron supplementation with ferrous sulfate (FeSO₄) leads to significantly higher levels of non-transferrin-bound iron (NTBI) in the bloodstream compared to other iron compounds, which raises safety concerns for young children with malaria.

In contrast, iron compounds like sodium iron ethylenediaminetetraacetic acid (NaFeEDTA) and iron polymaltose show negligible NTBI responses, suggesting they may be safer alternatives for iron supplementation in areas where malaria is prevalent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Schümann, K., Solomons, NW., Romero-Abal, ME., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8418942/

Treatment of Iron Deficiency Anemia in CKD and End-Stage ... In aggregate, these studies suggest that ferric citrate is effective in treating iron deficiency anemia in patients with CKD not requiring dialysis and may also ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06521216

Different Oral Iron Dosing Regimens in Treatment ... Iron deficiency is common in patients with CKD and an important modifiable factor in treatment of anemia. In particular, the Kidney Disease: Improving Global ...

3. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/comparative-efficacy-of-oral-versus-intravenous-iron-supplementation-in-treating-anemia-among-chronic-kidney-disease-patients-3253/

Comparative Efficacy of Oral versus Intravenous Iron ... Conclusion: IV iron supplementation was more effective than oral iron in improving hemoglobin levels and iron stores among CKD patients, with better tolerance ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925000543

Systematic Review of the Effects of Iron on Cardiovascular ... Iron therapy may reduce the risk of heart failure and cardiovascular death in patients with CKD. Randomized trials evaluating the effects of iron on clinical ...

5. withpower.com withpower.com/trial/phase-4-renal-insufficiency-3-2019-18a17

Oral Iron for Chronic Kidney Disease (FeTCh-CKD Trial) 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 ...

6. kireports.org kireports.org/article/S2468-0249(25)00160-3/fulltext

Randomized, Positive-Controlled Study on the Efficacy and ... The IHOPE study evaluated the efficacy and safety of oral iron polysaccharide complex versus i.v. iron in Chinese patients on hemodialysis (HD).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00236977

Study Details | NCT00236977 | Comparison of Safety and ... The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal ...

8. ajkd.org ajkd.org/article/S0272-6386(21)00955-0/fulltext

Recent and Emerging Therapies for Iron Deficiency in ... This review describes diagnostic criteria for iron deficiency in chronic kidney disease, as well as mechanisms of functional and absolute iron deficiency and ...