Clinical trial NCT01554982: A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Official title: A Long-Term Safety Extension Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Disease
Kidney Failure
Renal Failure
Hyperphosphatemia
ESRD
Keywords: Participation Limited
Long Term
Safety Extension
Lead sponsor: Keryx Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.

Detailed description: This study was an open-label, 48-week safety extension of Study KRX-0502-304 (Study 304), to evaluate the safety of long-term use of KRX-0502 in subjects with ESRD for up to 2 years of cumulative exposure. Subjects who completed the Safety Assessment Period (SAP) and, if eligible, the Efficacy Assessment Period (EAP) of Study 304, independent of their assigned treatment arm in the SAP or EAP of Study 304, were eligible for participation in this long-term safety extension study. No new subjects were permitted to enter this study.

Eligibility criteria: Inclusion Criteria:

1. Males or non-pregnant, non-breast-feeding females who participated in the Safety Assessment Period (SAP), and if eligible, the Efficacy Assessment Period (EAP) of Study KRX-0502-304
2. Willing and able to give informed consent

Exclusion Criteria:

1. Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
2. Any subject in Study KRX-0502-304 SAP who early terminated from the trial
3. Any subject who participated in Study KRX-0502-304 but declined EAP
4. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
5. History of malignancy in the last five years
6. Previous intolerance to KRX-0502 (ferric citrate)
7. Intolerance to oral iron-containing products
8. Absolute requirement for oral iron therapy
9. Absolute requirement for Vitamin C (multivitamins \[Nephrocaps, Renaphro, etc.\] allowed)
10. Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
11. Inability to tolerate oral drug intake
12. Any other medical condition that rendered the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
13. Inability to cooperate with study personnel or history of noncompliance
14. Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.

Primary outcomes:
measure: Safety Parameters
timeFrame: 48 Weeks
Secondary outcomes:
Other outcomes:
measure: Serum Phosphorus- Baseline
timeFrame: Baseline
measure: Serum Phosphorus- Week 48
timeFrame: 48 weeks
measure: Ferritin- Baseline
timeFrame: Baseline
measure: Ferritin- Week 48
timeFrame: 48 weeks
measure: Transferrin Saturation (TSAT) - Baseline
timeFrame: Baseline
measure: TSAT- Week 48
timeFrame: 48 weeks
measure: Hemoglobin- Baseline
timeFrame: Baseline
measure: Hemoglobin- Week 48
timeFrame: 48 weeks
measure: IV Iron Use
timeFrame: 48 weeks
Locations:
city: Los Angeles
country: United States
facility: Veterans Administration Greater Los Angeles Health Care System
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Westminster
country: United States
facility: Western Nephrology and Metabolic Bone Disease, PC
state: Colorado
city: Augusta
country: United States
facility: Kidney Care Associates, LLC
state: Georgia
city: Chicago
country: United States
facility: Circle Medical Management
state: Illinois
city: Michigan City
country: United States
facility: DaVita Dialysis Unit 494/Nephrology Specialists, PC
state: Indiana
city: New Orleans
country: United States
facility: Dept of Internal Medicine, Nephrology & Hypertension
state: Louisiana
city: Bethesda
country: United States
facility: Washington Nephrology Associates
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Western New England Renal & Transplant Associates, PC
state: Massachusetts
city: Dearborn,
country: United States
facility: Nephrology Hypertension Clinic, PC
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Pontiac
country: United States
facility: Rochester Hills DaVita Dialysis
state: Michigan
city: Asheville
country: United States
facility: Asheville Kidney Center
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Nephrology Associates, PA
state: North Carolina
city: Durham
country: United States
facility: Duke University Dept of Medicine/Nephrology
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Dialysis Center
state: North Carolina
city: Canton
country: United States
facility: Clinical Research Limited
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute Nephrology Associates
state: Tennessee
city: Nashville
country: United States
facility: Nephrology Associates, PC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Kidney Associates, PLLC
state: Texas
city: Houston
country: United States
facility: Med Center Dialysis
state: Texas
city: Houston
country: United States
facility: Kidney Specialists of North Houston, PLLC
state: Texas
city: Burlington
country: United States
facility: University of Vermont/ Fletcher Allen Health Care: Renal Services
state: Vermont
city: Charlottesville
country: United States
facility: Nephrology Clinical Research Center
state: Virginia
city: Fairfax
country: United States
facility: Clinical Research & Consulting Center, LLC
state: Virginia
city: Fairfax
country: United States
facility: Nephrology Associates of Northern Virginia, Inc.
state: Virginia
city: Hampton
country: United States
facility: Butler Farms Dialysis
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Rio Piedras
country: Puerto Rico
facility: RCMI-Clinical Research Center
Study officials:
affiliation: Collaborative Study Group
name: Julia B Lewis, MD
role: STUDY_CHAIR
References: