What is the mechanism of action of this treatment?

Common treatments for Chronic Kidney Disease (CKD) include iron supplementation, antihypertensive medications, and erythropoiesis-stimulating agents (ESAs). Iron sulfate replenishes iron stores, which is essential for hemoglobin production and oxygen transport, addressing anemia commonly seen in CKD patients. Antihypertensive medications, such as ACE inhibitors and ARBs, help control blood pressure and reduce proteinuria, thereby slowing the progression of kidney damage. ESAs stimulate red blood cell production, combating anemia and improving quality of life. These treatments are vital for managing CKD symptoms and preventing further complications.

What side effects are associated with this type of intervention?

Iron sulfate, commonly used to treat iron deficiency in Chronic Kidney Disease (CKD), often causes gastrointestinal side effects such as constipation, diarrhea, nausea, and abdominal pain. Other treatments for CKD, like erythropoiesis-stimulating agents (ESAs), can lead to hypertension, increased risk of thromboembolic events, and headaches. Phosphate binders, another common treatment, may result in gastrointestinal discomfort and hypercalcemia.

What prior FDA approvals exist?

The FDA has approved several treatments for managing anemia in Chronic Kidney Disease (CKD), focusing on iron supplementation and erythropoiesis-stimulating agents (ESAs). Iron sulfate is a commonly used oral iron supplement that helps replenish iron stores, essential for hemoglobin production and oxygen transport. Other FDA-approved iron therapies include intravenous iron formulations such as ferric carboxymaltose and iron sucrose, which are often used when oral iron is insufficient or not tolerated. Additionally, ESAs like epoetin alfa and darbepoetin alfa are approved to stimulate red blood cell production in CKD patients with anemia. These treatments aim to improve hemoglobin levels and reduce the need for blood transfusions.

What other types of research exist?

Promising novel alternatives to Iron Sulfate for CKD patients include intravenous iron formulations such as ferric carboxymaltose and ferric derisomaltose. These formulations are effective in rapidly replenishing iron stores and improving hemoglobin levels with a favorable safety profile. Additionally, newer oral iron supplements like ferric maltol offer improved gastrointestinal tolerance and better absorption compared to traditional iron sulfate.

← Back to Search

Iron Supplement

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

Phase 4

Recruiting

Led By Oleh Akchurin, M.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children with transferrin saturation ≤ 20% AND serum ferritin ≤ 100 ng/mL will be randomized into one of the arms

Hb less than 11.5 g/dL in children younger than 5 years Hb less than 12.0 g/dL in children 5-12 years Hb <12.5 g/dL in children 12-15 yrs and females >15 yrs. Hb <13.5 g/dL in males >15 years (all at the previous clinic visit)

Must not have

Rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months

Children on hemodialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 and 3 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from ferrous sulfate include stomach upset, constipation or diarrhea. These are common when starting iron supplements but often lessen over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child has low iron levels, with specific blood test results.

Select...

My last blood test showed low hemoglobin for my age and gender.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

My child is currently receiving hemodialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Muscle Tissue

Change in the percentage of transferrin saturation in the participants' blood

Secondary study objectives

Change in eating behavior

Change in quality of life: PROMIS

Change in sedentary time

+1 more

Side effects data

From 2004 Phase 3 trial • 182 Patients • NCT00236977

Dysgeusia

Oedema peripheral

Diarrhea NOS

Constipation

Dizziness

Hypertension NOS

Nausea

Oedema NOS

Fatigue

Vomiting NOS

Fecal Occult Blood Positive

Hypotension NOS

Respiratory failure

Renal failure acute

Sepsis NOS

Fluid Overload

Mental status changes

Pleural effusion

Intraoperative haemorrhage

Lobar pneumonia NOS

Urinary Tract Infection NOS

Hyponatraemia

Angina pectoris

Dyspnea

Flank pain

100%

80%

60%

40%

20%

Study treatment Arm

Venofer

Ferrous Sulfate

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ferrous Sulfate

2003

Completed Phase 4

~1470

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Kidney Disease (CKD) include iron supplementation, antihypertensive medications, and erythropoiesis-stimulating agents (ESAs). Iron sulfate replenishes iron stores, which is essential for hemoglobin production and oxygen transport, addressing anemia commonly seen in CKD patients. Antihypertensive medications, such as ACE inhibitors and ARBs, help control blood pressure and reduce proteinuria, thereby slowing the progression of kidney damage. ESAs stimulate red blood cell production, combating anemia and improving quality of life. These treatments are vital for managing CKD symptoms and preventing further complications.

Dialysis symptom index burden and symptom clusters in a prospective cohort of dialysis patients.Established and Emerging Strategies in the Treatment of Chronic Kidney Disease.