Ferric Citrate and Chronic Kidney Disease in Children (FIT4KID)
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|ClinicalTrials.gov Identifier: NCT04741646|
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : September 7, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases||Drug: Ferric Citrate Drug: Placebo||Phase 2|
We will conduct a double-blind, randomized, placebo-controlled trial to assess the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels (iFGF23, primary endpoint) aged 6-17 years of either sex with chronic kidney disease (CKD) stages 3-4 and age-appropriate normal serum phosphate levels. Participants will be randomized to one of the two groups: 1) FC or 2) FC placebo. Participants will be recruited from 12 core clinical sites.
Schedule of Intervention: During the 12-month trial, participants will be given a daily fixed weight-based dose of FC.
Schedule for data collection/analyses to be performed:
Blood for primary outcome assessments will be collected at screening, baseline and at months 1, 2, 3, 6, 9, 12. Blood for safety assessments will be collected at the same intervals.
The primary analyses for this 2-arm trial will evaluate changes from baseline in iFGF23 levels over 12 months between the treatment and the placebo arms. The analysis will use a linear mixed-effects model, with random participant effects accounting for repeated measurements, random site effects accounting for clustering of participants into study sites, and a fixed treatment effect, which interacts with a time indicator (Months 3-12 vs. Months 1-3).
- To assess the effects of therapy with FC on changes in iFGF23 levels
- To determine safety and tolerability of FC.
• To assess the effects of FC on anemia and indices of mineral and bone metabolism.
• Change in iFGF23 level
Safety and Tolerability Endpoints:
• Ability to safely tolerate FC
- Change in anemia
- Change in the indices of mineral and bone metabolism
This is a Phase 2 study with participation from 12 sites that will take 36 months to complete enrollment and a total of 48 months to complete data collection with each participant being part of the study for 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phosphate Binder Therapy and Chronic Kidney Disease in Children|
|Actual Study Start Date :||May 16, 2022|
|Estimated Primary Completion Date :||December 1, 2025|
|Estimated Study Completion Date :||December 1, 2025|
Experimental: Treatment Arm
During the 12-month trial, participants will be given a fixed weight-based dose of Ferric Citrate (FC). The full medication dose will be 3g/day for participants weighing <31 kg, 5g/day for those weighing >31 - <51 kg, and 6g/day for participants >51 kg. These doses will be divided into three doses to be taken with meals.
Drug: Ferric Citrate
Auryxia® 210 mg ferric iron tablets equivalent to 1 g of FC and matching placebo will be supplied as 200 tablets in 400cc high-density polyethylene bottles.
Other Name: Auryxia
Placebo Comparator: Control Arm
During the 12-month trial, participants will be given a fixed weight-based dose of Placebo. The full medication dose will be 3g/day for participants weighing <31 kg, 5g/day for those weighing >31 - <51 kg, and 6g/day for participants >51 kg. These doses will be divided into three doses to be taken with meals.
Placebo to match Ferric Citrate tablets
- iFGF23 levels [ Time Frame: 6 months and 12 months ]Change in iFGF23 levels
- Safety of Ferric Citrate [ Time Frame: 12 months ]Safety of FC will be compared to Placebo through measures of Adverse Events
- Tolerability of Ferric Citrate [ Time Frame: 12 months ]Tolerability of FC will be compared to Placebo through measures of Adverse Events
- Effects on Hemoglobin [ Time Frame: 12 months ]Increase in Hemoglobin will be compared between FC and Placebo
- Effects on TSAT [ Time Frame: 12 months ]Increase in TSAT will be compared between FC and Placebo
- Effects on Ferritin [ Time Frame: 12 months ]Increase in Ferritin will be compared between FC and Placebo
- Effects on PTH [ Time Frame: 12 months ]Increase in PTH will be compared between FC and Placebo
- Effects on 1,25 D [ Time Frame: 12 months ]Decrease in 1,25 D will be compared between FC and Placebo
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||6 Years to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Ages 6 to 17 years (inclusive);
- Estimated GFR of 15-59 ml/min per 1.73 m2 by modified CKiD formula;56
- Serum phosphate within age appropriate normal levels;
- Serum ferritin <500 ng/ml and TSAT <50%;
- For those patients treated with growth hormone, calcitriol, nutritional vitamin D, iron, and/or ESAs such treatments must have stable dosing for at least 2 weeks prior to screening;
- Able to swallow tablets;
- Able to eat at least two meals a day;
- In the opinion of the investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations.
- Perform physical exam and obtain vitals.
- Check urine pregnancy test in menstruating female participants and administer corresponding questionnaire.
- Administer GI Symptom questionnaire.
- Ascertain AEs.
- Obtain information on concomitant medications.
- Process 24-hour urine sample for 24 hour urine creatinine and phosphate.
- Measure run-in adherence using eCAP system and pill count.
- Administer the Medical Adherence Measure tool.
- Reinforce adherence.
- Prepare one month's supply of drug and enter them into eCAP system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04741646
|Contact: JENNY BROOK, MSfirstname.lastname@example.org|
|Contact: Barbara Gales, RNemail@example.com|
|United States, California|
|University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Barbara Gales, RN 310-206-0799 firstname.lastname@example.org|
|Principal Investigator: Isidro Salusky, MD|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Daniel Schrader 415-476-9657 email@example.com|
|Principal Investigator: Farzana Perwad, MD|
|Sub-Investigator: Anthony Portale, MD|
|United States, Florida|
|Arnold Palmer Hospital for Children||Not yet recruiting|
|Orlando, Florida, United States, 32806|
|Principal Investigator: Jorge Ramirez, MD|
|United States, Georgia|
|Emory University||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Anjali Khanna 470-867-7765 firstname.lastname@example.org|
|Contact: Mone Anzai 404-712-9923 email@example.com|
|Principal Investigator: Laurence Greenbaum, MD|
|United States, Missouri|
|Children's Mercy Hospital, Kansas City||Not yet recruiting|
|Kansas City, Missouri, United States, 64110|
|Contact: Stephen Morrison 816-302-3573 firstname.lastname@example.org|
|Principal Investigator: Bradley Warady, MD|
|United States, New York|
|Children's Hospital at Montefiore||Not yet recruiting|
|Bronx, New York, United States, 10467|
|Contact: Patricia Flynn 718-655-1120 email@example.com|
|Principal Investigator: Frederick Kaskel, MD|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Elizabeth Siry 513-636-7832 Elizabeth.Siry@cchmc.org|
|Principal Investigator: Mark Mitsnefes, MD|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Hannah Derwick DERWICKH@chop.edu|
|Principal Investigator: Michelle Denburg, MD|
|United States, Texas|
|Children's Medical Center, Dallas||Not yet recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Melaku Lemma 214-456-8577 firstname.lastname@example.org|
|Principal Investigator: Raymond Quigley, MD|
|Baylor College of Medicine||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Saima Deen 832-824-7783 email@example.com|
|Principal Investigator: Poyyapakkam R Srivanthos, MD|
|Canada, British Columbia|
|BC Children's Hospital Research Institute||Not yet recruiting|
|Vancouver, British Columbia, Canada, V5Z 4H4|
|Contact: Mike Guron 604-875-2000 ext 7255 firstname.lastname@example.org|
|Contact: Julie Matheson 604-875-2000 ext 7558 email@example.com|
|Principal Investigator: Tom Blydt-Hansen, MD|
|Principal Investigator:||Isidro B Salusky, MD||University of California, Los Angeles|
|Responsible Party:||Isidro Salusky, MD, Distinguished Professor of Pediatrics at the David Geffen School of Medicine at UCLA, Chief of Pediatric Nephrology and Director of the Pediatric Dialysis Program, University of California, Los Angeles|
|Other Study ID Numbers:||
1U01DK122013-01 ( U.S. NIH Grant/Contract )
1U01DK122013 ( U.S. NIH Grant/Contract )
|First Posted:||February 5, 2021 Key Record Dates|
|Last Update Posted:||September 7, 2022|
|Last Verified:||May 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Renal Insufficiency, Chronic