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Phosphate Binder
Ferric Citrate for Chronic Kidney Disease
Phase 3
Recruiting
Research Sponsored by Keryx Biopharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented history of CKD-related hyperphosphatemia for at least 3 months prior to the screening visit
Weight ≥ 40 kilograms (kg) (dry weight for dialysis participants) at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 40
Awards & highlights
Study Summary
This trial will look at how safe & tolerated ferric citrate is for children with kidney disease & high phosphate levels.
Who is the study for?
This trial is for children with chronic kidney disease (CKD) who have high phosphate levels. They must have been on dialysis or have an eGFR <30 mL/min/1.73 m^2, weigh at least 40 kg, and not be pregnant. Participants need a history of CKD-related hyperphosphatemia for 3+ months and agree to birth control if applicable.Check my eligibility
What is being tested?
The study tests the safety and tolerability of ferric citrate in pediatric patients with hyperphosphatemia due to CKD. It aims to see how well these young patients handle the medication over time.See study design
What are the potential side effects?
Potential side effects may include digestive issues like upset stomach or constipation, changes in blood iron levels, and possibly allergic reactions for those sensitive to ferric citrate or its components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had high phosphate levels due to kidney disease for at least 3 months.
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I weigh at least 40 kilograms.
Select...
My peritoneal dialysis efficiency is adequate.
Select...
My child and I agree to participate in the study, and I can provide consent.
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I have chronic kidney disease and am on dialysis or have an eGFR under 30 mL/min.
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I am a woman who can have children and have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 40
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 40
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with TEAEs leading to the discontinuation of ferric citrate
Number of participants with clinically significant laboratory abnormalities or changes in laboratory results
Number of participants with serious and non-serious treatment-emergent adverse events (TEAEs) including gastrointestinal (GI) AEs of special interest
Secondary outcome measures
Change from baseline in serum phosphorus to Week 12/early termination (ET)
Side effects data
From 2014 Phase 3 trial • 168 Patients • NCT0155498216%
Diarrhoea
10%
Vomiting
10%
Nausea
8%
Dyspnoea
8%
Faeces discoloured
8%
Headache
7%
Arteriovenous fistula site complication
7%
Cough
7%
Pain in extremity
6%
Hypotension
6%
Renal transplant
6%
Pneumonia
6%
Musculoskeletal pain
6%
Nasopharyngitis
6%
Oedema peripheral
5%
Pyrexia
5%
Sepsis
5%
Constipation
5%
Dizziness
5%
Fall
5%
Hypertension
5%
Vascular graft complication
4%
Cardiac arrest
3%
Fluid overload
2%
Atrial fibrillation
2%
Angina pectoris
2%
Mental disorder
2%
Non-cardiac chest pain
2%
Syncope
2%
Acute myocardial infarction
2%
Cardiac failure congestive
2%
Hyperkalaemia
2%
Pleural effusion
2%
Pulmonary oedema
1%
Chest pain
1%
Tachycardia
1%
Thrombocytopenia
1%
Bradycardia
1%
Pleuropericarditis
1%
Cerebral thrombosis
1%
Transient ischaemic attack
1%
Arteriovenous fistula thrombosis
1%
Oxygen saturation decreased
1%
Catheter placement
1%
Spinal fusion surgery
1%
Aneurysm
1%
Brachiocephalic vein stenosis
1%
Deep vein thrombosis
1%
Lymphadenopathy
1%
Ischaemic cardiomyopathy
1%
Myocardial infarction
1%
Pericardial effusion
1%
Lower gastrointestinal haemorrhage
1%
Peritonitis
1%
Rectal haemorrhage
1%
Retroperitoneal haematoma
1%
Umbilical hernia, obstructive
1%
Arteriovenous graft site infection
1%
Bacteraemia
1%
Cellulitis streptococcal
1%
Device related infection
1%
Furuncle
1%
Gangrene
1%
Liver abscess
1%
Localised infection
1%
Meningitis viral
1%
Osteomyelitis
1%
Perirectal abscess
1%
Postoperative wound infection
1%
Postoperative wound complication
1%
Subdural haematoma
1%
Peripheral vascular disorder
1%
Sudden death
1%
Bacterial sepsis
1%
Cellulitis
1%
Peritoneal dialysis
1%
Necrosis
1%
Abscess limb
1%
Diverticulitis intestinal haemorrhagic
1%
Diverticulum intestinal haemorrhagic
1%
Gastrointestinal haemorrhage
1%
Haematemesis
1%
Ileus paralytic
1%
Death
1%
Ventricular fibrillation
1%
Ventricular tachycardia
1%
Vertigo positional
1%
Hyperparathyroidism
1%
Incision site abscess
1%
Infected skin ulcer
1%
Klebsiella bacteraemia
1%
Peritoneal abscess
1%
Septic shock
1%
Staphylococcal bacteraemia
1%
Staphylococcal infection
1%
Humerus fracture
1%
Joint dislocation
1%
Vascular graft thrombosis
1%
Wound dehiscence
1%
Wound haemorrhage
1%
Aspiration pleural cavity
1%
Diabetic foot
1%
Hypocalcaemia
1%
Lactic acidosis
1%
Metabolic encephalopathy
1%
Arthritis
1%
Back pain
1%
Lumbar spinal stenosis
1%
Musculoskeletal chest pain
1%
Neuropathic arthropathy
1%
Osteoarthritis
1%
Spinal osteoarthritis
1%
Systemic lupus erythematosus
1%
Lung neoplasm malignant
1%
Unresponsive to stimuli
1%
Paraparesis
1%
Disorientation
1%
Acute pulmonary oedema
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Asthma
1%
Pneumonia aspiration
1%
Pulmonary embolism
1%
Respiratory distress
1%
Respiratory failure
1%
Angioedema
1%
Cardiac pacemaker insertion
1%
Leg amputation
1%
Parathyroidectomy
1%
Hypertensive crisis
1%
Hypertensive emergency
1%
Hypoglycemia
1%
Abdominal Abscess
1%
Pelvic abscess
1%
Complications of transplant surgery
1%
Dehydration
1%
Azotaemia
1%
Leukocytosis
1%
Confusional state
1%
Postmenopausal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ferric Citrate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ferric citrateExperimental Treatment1 Intervention
Participants aged 6 to < 17 years will receive ferric citrate for 36 weeks at a starting dose based on body weight categories.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ferric citrate
2010
Completed Phase 3
~880
Find a Location
Who is running the clinical trial?
Keryx BiopharmaceuticalsLead Sponsor
20 Previous Clinical Trials
4,114 Total Patients Enrolled
8 Trials studying Hyperphosphatemia
1,133 Patients Enrolled for Hyperphosphatemia
Chief Medical OfficerStudy DirectorAkebia Therapeutics Inc.
123 Previous Clinical Trials
21,649 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age requirement for this trial extend beyond sixty years of age?
"This medical trial is enrolling patients aged between 12 and 17."
Answered by AI
To what extent is this trial being conducted across various medical clinics?
"The current medical trial is being held at 13 distinct sites, including Phoenix, San Francisco and Stanford. To reduce travel costs associated with participation, please consider selecting the closest site to your residence."
Answered by AI
Is this research endeavor currently recruiting participants?
"The data on clinicaltrials.gov attests that this medical trial is still seeking volunteers, with its initial posting occurring on June 8th 2023 and the most recent update being made October 19th of the same year."
Answered by AI
Is Ferric citrate a risk-free solution for patients?
"There is some scientific evidence affirming the effectiveness of Ferric citrate, and multiple reports that vouch for its safety; thus it was scored a 3."
Answered by AI
Could I qualify to join this research endeavor?
"Eligibility for this trial requires the patient to have hyperphosphatemia and be between 12-17 years of age. In total, 45 participants are being recruited."
Answered by AI
How many individuals have enrolled in this experiment?
"To successfully conduct the trial, 45 participants conforming to the study's parameters must join. Those interested can enrol at Phoenix Childrens Hospital in Arizona or University of California San Francisco – Department of Nephrology situated in California."
Answered by AI
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