A Long-Term Safety Extension Trial of Ferric Citrate in Patients With End-Stage Renal Disease (ESRD) on Dialysis

End Stage Renal Disease Clinical Trial

Official title:

A Long-Term Safety Extension Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554982
• Other study ID #: KRX-0502-307
• Status: Completed
• Phase: Phase 3
• First received: March 12, 2012
• Last updated: August 6, 2014
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Keryx Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males or non-pregnant, non-breast-feeding females who participated in the Safety Assessment Period, and if eligible, the Efficacy Assessment Period 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 who early terminated from the trial

3. Any subject who participated in Study KRX-0502-304 but declined

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 renders 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• ESRD
• Hyperphosphatemia
• Kidney Diseases
• Kidney Failure
• Kidney Failure, Chronic
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• ferric citrate
Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keryx Biopharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Parameters	Safety will be assessed by recording and monitoring AEs, SAEs, and sequential laboratory data. Rates of adverse events will be summarized by organ system class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).	48 Weeks	Yes
Secondary	Efficacy Parameters	The changes from baseline in laboratory parameters (including serum phosphorus, TSAT, ferritin, hemoglobin, and hematocrit) over time and at study completion will also be summarized.	48 Weeks	No