Skip to main content
OpenTrials
Completed

NCT Number: NCT01736397

Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis

The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Iron Deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tempe, Arizona, United States

Loading trial locations.

About this study

This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical trial. Following a Screening and Qualification Period and a two-week Washout Period (for those subjects entering the study on a phosphate binder), eligible subjects will be randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic CKD subjects not on dialysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage III to V Chronic Kidney Disease
  • Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
  • Ferritin 300 ng/mL or less
  • Transferrin Saturation (TSAT) 30% or less
  • Hemoglobin >9.0 and <12.0 g/dL
  • Must consume a minimum of 2 meals per day

Exclusion criteria

  • Parathyroidectomy within 24 weeks of study
  • gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
  • Requirement for dialysis or kidney injury within 8 weeks of study
  • Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
  • Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
  • Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
  • History of hemochromatosis
  • Allergy to iron products
  • History of malignancy in last 5 years

Treatment and study plan

Ferric citrate

Drug

Dose depends on serum phosphorus levels collected at each study visit.

Other names: KRX-0502

Placebo

Drug

Primary outcomes

  1. Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment

    Time frame: 12 Weeks

    The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.

  2. Change in Serum Phosphorus Levels From Baseline to End of Treatment

    Time frame: 12 Weeks

    The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.

Secondary outcomes

  1. Change in Ferritin Levels From Baseline to End of Treatment

    Time frame: 12 Weeks

    The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement.

  2. Change in Hemoglobin Levels From Baseline to End of Treatment

    Time frame: 12 Weeks

    The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement.

Sponsors and collaborators

Lead sponsor

Keryx Biopharmaceuticals

Industry

Registry information

Official study title

A Phase 2 Study of KRX-0502 (Ferric Citrate) in Managing Serum Phosphorus and Iron Deficiency in Anemic Subjects With Stage III to V Chronic Kidney Disease Not on Dialysis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2012
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.