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Oral Iron for Chronic Kidney Disease (FeTCh-CKD Trial)
FeTCh-CKD Trial Summary
This trial will test whether oral iron therapy can improve muscle strength, physical activity, and eating behavior in children with CKD and mild anemia.
FeTCh-CKD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFeTCh-CKD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2004 Phase 3 trial • 182 Patients • NCT00236977FeTCh-CKD Trial Design
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Who is running the clinical trial?
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- My kidney function is quickly getting worse, and I might need dialysis or a transplant soon.I am between 1 and 21 years old.Your blood ferritin level is less than 10 ng/mL.You are pregnant or breastfeeding.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.My child has low iron levels, with specific blood test results.My last blood test showed low hemoglobin for my age and gender.Your transferrin saturation level is less than 5%.My child is currently receiving hemodialysis.I haven't had iron or erythropoietin therapy in the last 3 months.I have not had a blood transfusion in the last 4 months.
- Group 1: Oral Iron therapy
- Group 2: No oral iron therapy
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there any hazard associated with Ferrous Sulfate intake?
"Ferrous Sulfate has reached the apex of safety assessment, scoring a 3 on our rating scale due to its Phase 4 trial status. This implies that this medication is officially approved by health regulators."
Could you provide an overview of prior studies conducted with Ferrous Sulfate?
"As of now, 78 active investigations into Ferrous Sulfate are underway with 35 in Phase 3. Most experiments on the medicine take place at a medical centre located in Sioux Falls, South dakota; however, there is an extensive network of 9903 sites conducting clinical research concerning this drug."
How many participants are being enrolled in this research endeavor?
"Indeed, clinicaltrials.gov indicates that the research is actively recruiting participants since it was first posted on April 19th 2019 and edited most recently on October 18th 2022. The team needs to find 60 individuals from two medical facilities."
What objectives are researchers aiming to achieve with this experiment?
"The major outcome of this medical study, which will be observed during a 0 and 3 months duration, is the variance in transferrin saturation levels. Secondary indicators include fluctuation in skeletal muscle mass (calculated via bio-electrical impedance analysis), quality of life metrics as determined by PROMIS - an NIH developed tool that uses T-score to assess fatigue and physical activity - as well as changes in eating habits assessed with CEBQ questionnaires composed of 35 items."
What medical applications does Ferrous Sulfate typically fulfill?
"Ferrous Sulfate is a viable therapy for individuals suffering from folic acid deficiency, hypochromic anemia, and lactating women."
Who can partake in this medical experiment?
"Candidates between the age of 1 Year and 21 with chronic kidney diseases can apply for this research study, which will enroll around 60 participants."
Are there vacancies for interested participants in this clinical research?
"Affirmative. According to clinicaltrials.gov, the trial is actively recruiting patients with an original posting date of April 19th 2019 and a most recent edit on October 18th 2022. In order to meet their goals they must find 60 individuals between two sites."
Is the enrollment age limit for this trial greater than 80 years?
"Applicants that meet the criteria for this trial must have a minimum age of 1 and not exceed 21 years old. There are 93 studies open to minors, while 593 trials target individuals over 65."
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