A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00648167
• Date of registration: 27/03/2008
• Primary sponsor: Keryx Biopharmaceuticals
• Public title: A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
• Scientific title: A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
• Date of first enrolment: March 2008
• Target sample size: 55
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00648167
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and non-pregnant, nonlactating females

- Age > 18 years

- On thrice weekly hemodialysis for at least the previous 3 months prior to
randomization

- Phosphorous levels =3.5mg/dL at Screening Visit

- On at least 12 tablets/capsules/day of calcium acetate (667mg), calcium carbonate
(500mg), lanthanum carbonate (500mg), sevelamer hydrochloride (800mg or two 400mg
tablets), or any combination of these agents

- Serum ferritin <1000micrograms/L and TSAT <50%

- Willing to be discontinued from current phosphate binder(s) and initiated on Zerenex

- Willing and able to give informed consent

Exclusion Criteria:

- Parathyroidectomy within 6 months prior to Screening

- Actively symptomatic GI disease such as peptic ulcer disease, gastro esophageal
reflux, diverticulosis, irritable bowel syndrome (treated asymptomatic is permitted)

- History of documented inflammatory bowel disease or erosive esophagitis

- Serum Phosphorus levels >10.0 mg/dL documented in the 3 monthly laboratories (done
routinely in the dialysis unit) in the 3 months prior to the Screening Visit

- History of multiple drug allergies

- History of malignancy in the last 5 years (treated cervical or skin cancer may be
permitted if approved by CCC)

- Previous intolerance to oral ferric citrate

- Absolute requirement for oral iron therapy

- Absolute requirement for Vitamin C (multivitamins [Neprocaps, 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 study (scheduled outpatient access
surgery allowed)

- Any other medical condition that renders the patient unable to or unlikely to
complete the study or that would interfere with optimal participation in the study or
produce significant risk to the patient

- Receipt of any investigational drug within 30 days of randomization

- Inability to cooperate with study personnel or history of noncompliance



Age minimum: 19 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

End-stage Renal Disease

Hyperphosphatemia

Intervention(s)

Drug: ferric citrate

Primary Outcome(s)

This study is exploratory in nature and is intended to assess the tolerability and safety of Zerenex. [Time Frame: 4-10 months]

Secondary Outcome(s)

Serum phosphorus levels will be monitored prior to study drug titration. [Time Frame: 4-10 months]

Secondary ID(s)

KRX-0502-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Collaborative Study Group (CSG)