HyperphosphatemiaPhase 3NCT01503736
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease
A Phase 3 study testing ferric citrate in people with Hyperphosphatemia and End Stage Renal Disease, run by Panion & BF Biotech Inc. at 5 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphatemia, End Stage Renal Disease, ESRD
- What is being tested?
- ferric citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 5 sitesTaiwan
- Study dates
- Jun 2010to Jun 2012
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City
Division of Nephrology, Keelung Chang Gung Memorial Hospital
Keelung
Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
New Taipei City
Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
Taichung
Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
Taipei
About this study
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
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).
- Conditions
- Hyperphosphatemia, End Stage Renal Disease, ESRD
- Being tested
- ferric citrate
- Keywords
- Kidney Diseases, Kidney Failure, Chronic, Hyperphosphatemia, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, Phosphorus Metabolism Disorders
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic, Kidney Diseases, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, Phosphorus Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferric citrateDrug
0g/day ferric citrate capsule, TID for 56 days
ferric citrateDrug
4g/day ferric citrate capsule, TID for 56 days
ferric citrateDrug
6 g/day ferric citrate capsule, TID for 56 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: ferric citrate |
| 4g/day | Experimental | Ferric Citrate for a total daily dose of 4g Receives: Drug: ferric citrate |
| 6g/day | Experimental | Ferric Citrate for a total daily dose of 6g Receives: Drug: ferric citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum phosphorus at Day 56 as compared to baseline
Measured: Day 56
Secondary outcomes (5)
Change in serum phosphorus at Day 28 as compared to baseline
Measured: Day 28
Change in Ca x P product at Day 56 compared to baseline
Measured: Day 56
Change in Ca x P product at Day 28 compared to baseline
Measured: Day 28
Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56
Measured: Day 56
Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startJun 2010
- Primary completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panion & BF Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503736
- Sponsor's protocol ID
- PNC00301
- Status last verified
- Jan 2020
- First submitted
- 2 Jan 2012
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24840781Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086