Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients

Hyperphosphatemia Clinical Trial

Official title:

Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079869
• Other study ID #: FeCitrate
• Secondary ID: 11035
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2017
• Est. completion date: September 14, 2019

Study information

• Verified date: January 2022
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

Description:

PROTOCOL SUMMARY

Title: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California

Short Title: FeCitrate

Protocol Number: KP FeCitrate

Study Phase: 4

Study Site(s): Los Angeles Kaiser Sunset Medical Center

Number of Subjects: 55

Study Arms: 1

Indication: Hyperphosphatemia in end stage renal disease

Primary Purpose: To evaluate the efficacy of ferric citrate for control of serum phosphorus levels and maintenance of adequate iron stores among dialysis-dependent patients before and after conversion from traditional phosphate binders in a "real world" environment

Overview of Study Design: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).

Investigational Product Administration: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.

Study Endpoint: Mean serum phosphorus levels and rate of successful phosphorus control (<5.5mg/dl) 6 months before and after treatment with ferric citrate

Statistical Methods: Not powered to detect statistical significance

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 14, 2019
• Est. primary completion date: September 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate

• Mean serum phosphorus 4.0-<8.0 mg/dl for 6 months prior to enrollment

• No allergy to iron

• Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment

• Mean PTH < 1000 pg/ml for 6 months prior to enrollment

• Mean ferritin < 1500 ng/ml and mean iron sat < 50% for 6 months prior to enrollment

Exclusion Criteria:

• History of gastrointestinal bleeding within past 6 months

• History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months

• Acute kidney injury equal to or less than 3 months before the initial screening date

• Active malignancy

• Functioning renal transplant

• Patients with iron overload syndrome (e.g., Hemochromatosis)

• History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease

• Active or past history of calciphylaxis

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• Ferric Citrate
One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.

Locations

Country	Name	City	State
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Keryx Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phosphorus Levels	Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use	6 months
Secondary	Intravenous (IV) Iron	The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.	6 months
Secondary	Erythropoiesis Stimulating Agents (ESA) Dose	Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome.	6 months
Secondary	Median Pill Count	median pill count of ferric citrate pills/day required to maintain phosphorus control	6 months