Clinical trial NCT01503736: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Definitive Phase III Study of the Effects of Ferric Citrate on Serum Phosphate in Subjects With End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperphosphatemia
End Stage Renal Disease
ESRD
Keywords: Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders
Lead sponsor: Panion & BF Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-04
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).


Eligibility criteria: Inclusion Criteria:

* Age\>18 years and has a diagnosis of ESRD
* On a three-times per week hemodialysis regimen
* On a stable dose of a phosphate-binding agent for at least one month prior to study entry.
* If on vitamin D supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry.
* Hct \>= 20%
* Serum Ca level of 8 mg/dL to 10.5 mg/dL

Exclusion Criteria:

* Is pregnant or lactating
* Clinically significant GI disorder
* Has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma Ca is \<7 mg/dL)
* ferritin\>800 ng/mL
* Unstable medical condition unsuitable for the study in the opinion of investigator
* Has been treated with an investigational agent within 30 days of enrollment
* Has a history of documented iron allergy or hemochromatosis

Primary outcomes:
measure: Change in serum phosphorus at Day 56 as compared to baseline
timeFrame: Day 56
Secondary outcomes:
measure: Change in serum phosphorus at Day 28 as compared to baseline
timeFrame: Day 28
measure: Change in Ca x P product at Day 56 compared to baseline
timeFrame: Day 56
measure: Change in Ca x P product at Day 28 compared to baseline
timeFrame: Day 28
measure: Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56
timeFrame: Day 56
measure: Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28
timeFrame: Day 28
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
city: Keelung
country: Taiwan
facility: Division of Nephrology, Keelung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
city: Taichung
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
References:
citation: Lee CT, Wu IW, Chiang SS, Peng YS, Shu KH, Wu MJ, Wu MS. Effect of oral ferric citrate on serum phosphorus in hemodialysis patients: multicenter, randomized, double-blind, placebo-controlled study. J Nephrol. 2015 Feb;28(1):105-13. doi: 10.1007/s40620-014-0108-6. Epub 2014 May 20.