AzTrials
AzTrials

HyperphosphatemiaPhase 3NCT01074125

A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

A Phase 3 study testing ferric citrate in people with Hyperphosphatemia and End-Stage Renal Disease, run by Keryx Biopharmaceuticals at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperphosphatemia, End-Stage Renal Disease
What is being tested?
ferric citrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
16 sitesin 2 countries
Study dates
May 2010to Nov 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Males or non-pregnant, non-lactating females
  • Age > 18 years
  • On thrice weekly hemodialysis or peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0)
  • Serum phosphorus levels ≥ 3.5 mg/dL and < 8.0 mg/dL at Screening Visit (Visit 0)
  • Serum phosphorus levels > 6.0 mg/dL during the washout period (Visits 2 or 3)
  • Taking 3 to 15 tablets/capsules per day of 667mg calcium acetate or 800 mg sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at Screening Visit (Visit 0)
Show all 10Show fewer
  • Serum ferritin <1000micrograms/L and Transferrin Saturation (TSAT) <50% at the Screening Visit (Visit 0)
  • Willingness to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)
  • Willing and able to give informed consent
  • Willing and able to stay on a constant dose of Vitamin D (or its analogs) and Sensipar (cinacalcet) for the treatment period, if applicable.

Who cannot join

  • Parathyroidectomy within six months prior to Screening Visit (Visit 0)
  • Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
  • Serum phosphorus levels >10.0 mg/dL documented in all of the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0)
  • History of multiple drug allergies or intolerances
  • History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
  • Previous intolerance to oral ferric citrate
Show all 16Show fewer
  • Absolute requirement for oral iron therapy
  • Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)
  • Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
  • Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
  • Inability to tolerate oral drug intake
  • Planned surgery or hospitalization during the trial (scheduled outpatient access surgery allowed)
  • Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient
  • Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
  • Inability to cooperate with study personnel or history of noncompliance
  • Unsuitable for this trial per Principal Investigator's clinical judgment

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

United States15 sites

  • Kidney Care Associates, LLC

    Augusta, Georgia, 30901

  • Brookdale Physician's Dialysis Associates

    Brooklyn, New York, 11212

  • Southeast Renal Research Institute

    Chattanooga, Tennessee, 37404

  • Circle Medical Management

    Chicago, Illinois, 60607

  • DCI

    Cincinnati, Ohio, 45206

  • Cleveland Clinical Foundation Fresenius East (Fairhill)

    Cleveland, Ohio, 44104

  • The Ohio State University Cramblett Medical Clinic

    Columbus, Ohio, 43210

  • Kidney Associates

    Houston, Texas, 77030

  • Nephrology Associates, PC

    Nashville, Tennessee, 37205

  • Meharry Medical College Clinical Research Center

    Nashville, Tennessee, 37208

  • Vanderbilt University Medical Center Clinical Trials Center

    Nashville, Tennessee, 37232-1371

  • Pines Clinical Research, Inc.

    Pembroke Pines, Florida, 33028

  • Western New England Renal & Transplant Associates

    Springfield, Massachusetts, 01107

  • Centre Point Dialysis

    West Allis, Wisconsin, 53214

  • Western Nephrology

    Westminster, Colorado, 80031

Other trials in United States

Puerto Rico1 site

  • RCMI- Clinical Research Center Medical Sciences Campus University of Puerto Rico

    Rio Piedras, PR, 00936-5067

Other trials in Puerto Rico

About this study

Official title: A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) Following a Two-Week Washout Period

This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.

Read the detailed description

There will be a screening visit about 4 weeks receiving study drug. Upon qualifying for the study after the screening visit, patients will then be asked to stop taking their current phosphate binder for about 2 weeks. Then, if patients continue to qualify for the study, they will be entered in the study that lasts about 28 days. Study visits will happen every week during the patient's usual dialysis appointments. There will be a total of up to 9 visits for this study, and total participation time could last up to 8 weeks.

Being tested
ferric citrate
Keywords
Hyperphosphatemia, ESRD, Dialysis, End Stage Renal Disease, Phosphorus, Renal, Kidney
Medical subject headings
Hyperphosphatemia, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ferric citrateDrug

    Also called KRX-0502

    1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days

Study groups in NCT01074125
Study groupRoleWhat they receive
1 g/dayExperimental1 g/day KRX-0502 (ferric citrate)
Receives: Drug: ferric citrate
6 g/dayExperimental6 g/day KRX-0502 (ferric citrate)
Receives: Drug: ferric citrate
8 g/dayExperimental8 g/day KRX-0502 (ferric citrate)
Receives: Drug: ferric citrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Serum Phosphorus From Baseline to End of Treatment

    Mean change from baseline was calculated separately for each treatment arm (LOCF)

    Measured: Baseline and day 28

Secondary outcomes (2)

  1. Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment

    Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome.

    Measured: Baseline and day 28

  2. Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment

    proportion was calculated separately for each treatment arm

    Measured: Baseline and day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

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
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01074125
Sponsor's protocol ID
KRX-0502-305
Status last verified
Dec 2014
First submitted
17 Feb 2010
Last updated
4 Dec 2014
Data monitoring committee
Yes

Publications

  • Natale 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

  • Dwyer JP, Sika M, Schulman G, Chang IJ, Anger M, Smith M, Kaplan M, Zeig S, Koury MJ, Blumenthal SS, Lewis JB; Collaborative Study Group. Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial. Am J Kidney Dis. 2013 May;61(5):759-66. doi: 10.1053/j.ajkd.2012.11.041. Epub 2013 Jan 29.

    PubMed 23369827

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ferric citrate in people with Hyperphosphatemia and End-Stage Renal Disease, run by Keryx Biopharmaceuticals at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Serum Phosphorus From Baseline to End of Treatment (time frame: Baseline and day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01074125, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in