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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
Must not have
Unable to swallow pills, if participant requires tube feeding, ferric citrate must be taken orally and not administered via feeding tube
Active significant gastrointestinal (GI) disorder, including overt GI bleeding or active inflammatory bowel disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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 below
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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.
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My peritoneal dialysis efficiency is adequate.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot swallow pills and do not use a feeding tube for medication.
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I have a serious stomach or bowel condition, like bleeding or inflammation.
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I have a working organ transplant.
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My high phosphate levels are not due to kidney issues.
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I have a history of conditions causing too much iron in my body.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2014 Phase 3 trial • 168 Patients • NCT01554982
16%
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%
Angina pectoris
2%
Mental disorder
2%
Atrial fibrillation
2%
Non-cardiac chest pain
2%
Syncope
2%
Acute myocardial infarction
2%
Cardiac failure congestive
2%
Hyperkalaemia
2%
Pleural effusion
2%
Pulmonary oedema
1%
Pleuropericarditis
1%
Chest pain
1%
Thrombocytopenia
1%
Bradycardia
1%
Tachycardia
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Chief Medical OfficerStudy DirectorAkebia Therapeutics Inc.
126 Previous Clinical Trials
22,006 Total Patients Enrolled
~2 spots leftby Jan 2025
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