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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05085275
Other study ID # USRC-2021-002
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 30, 2022
Est. completion date August 2024

Study information

Verified date October 2023
Source USRC Kidney Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of time to initiation of maintenance dialysis or all-cause mortality.


Description:

This multicenter, randomized, double-blind, placebo-controlled clinical trial is being conducted to determine the effect of ferric citrate on the time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality in patients with non-dialysis dependent, advanced CKD. Up to 400 subjects will be randomized in 1:1 ratio to receive either ferric citrate or matching placebo. All subjects will initiate dosing at 2 tablets per meal or snacks, up to 3 times per day (maximum of 6 tablets per day). The dose of ferric citrate/placebo will only be adjusted based on safety and/or tolerability. Given the double-blind design of this trial, investigators will be instructed to not prescribe commercial Auryxia to either study arm. Study visits during the treatment period are to be conducted as part of routine scheduled clinical encounters. Standard of care local laboratory results will be collected however no study specific laboratory tests other than a pregnancy test in women of child-bearing potential will be required.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult patients greater or equal to 18 years old. 2. Diagnosis of NDD advanced CKD, regardless of etiology. Advanced CKD is defined as at least one local laboratory determined estimated glomerular filtration rate (eGFR) =20 ml/min/1.73m2 (calculated per any commonly used method or equation for estimating eGFR) within 90 days of Day 1. 3. Most recent transferrin saturation (TSAT) less than or equal to 45% within 45 days of Day 1. 4. Most recent serum phosphate is greater or equal to 3.0 mg per dL within 45 days of Day 1. 5. Most recent ferritin is less than or equal to 500 ng per mL within 45 days of Day 1. 6. Women of child-bearing potential must have a negative serum or urine pregnancy test within 28 days prior to Day 1. 7. Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure. Exclusion Criteria: 1. Patients who, in the opinion of the Investigator, have acute kidney injury rather than CKD. 2. Patients with planned/imminent maintenance dialysis, or that are anticipated to begin maintenance dialysis within 8 weeks from Screening, in the opinion of the Investigator. 3. A known allergy or intolerance to ferric citrate or any of its constituents. 4. Hypersensitivity reaction to previous oral iron therapy. 5. History of hemochromatosis or iron overload syndrome (e.g., hereditary sideroblastic anemia, thalassemia, polycythemia vera). 6. Active malignancy requiring current treatment except for non-melanoma skin cancer regardless of treatment. 7. Active drug or alcohol dependence or abuse (excluding tobacco use or use of medical or recreational marijuana) within the 12 months prior to Screening or evidence of such abuse, in the opinion of the Investigator. 8. Limited life expectancy (less than 6 months) in the opinion of the Investigator. 9. Females who are known to be pregnant or are breast-feeding during Screening or are planning to become pregnant and breastfeeding during the study period. 10. Evidence of a clinically active infection requiring antibiotics at Randomization. 11. Unable to comply with study requirements or in the opinion of the Investigator, not clinically stable to participate in the study. 12. Use of an investigational medication or participation in an investigational study within 30 days prior to Day 1. 13. Patients with a scheduled date for receipt of living donor kidney transplant

Study Design


Intervention

Drug:
Ferric Citrate 1 GM Oral Tablet [AURYXIA]
All subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed.
Placebo
All subjects will be instructed to take study drug (ferric citrate or placebo) at a fixed dose of 2 tablets per meal or snacks, up to three times per day. The maximum dose is 6 tablets per day. No additional tablets (beyond a total of 6 per day) should be taken. Tablets should not be crushed or chewed.

Locations

Country Name City State
United States Dialysis Clinic, Inc. Albany Georgia
United States Nephrology Associates of Western NY Amherst New York
United States Balboa Research SMO Chula Vista California
United States Nephrology and Hypertension Specialists, PC Dalton Georgia
United States Balboa Research SMO El Centro California
United States Balboa Research SMO Escondido California
United States Associates in Nephrology Fort Myers Florida
United States High Desert Nephrology Associates Gallup New Mexico
United States Kidney Associates of Kansas City Kansas City Missouri
United States Dialysis Clinic, Inc. Knoxville Tennessee
United States Balboa Research SMO La Mesa California
United States South Texas Renal Care Group Live Oak Texas
United States Rocky Mountain Kidney Care Lone Tree Colorado
United States Arkansas Nephrology & Hypertension Clinic Pine Bluff Arkansas
United States Nephrology-Hypertension Associates of Central NJ S. River New Jersey
United States Clinical Advancement Center, PLLC San Antonio Texas
United States South Texas Renal Care Group San Antonio Texas
United States South Texas Renal Care Group San Antonio Texas
United States South Texas Renal Care Group San Antonio Texas
United States South Texas Renal Care Group San Antonio Texas
United States Balboa Research SMO - Kearney Mesa San Diego California
United States Major Health Partners Shelbyville Indiana
United States Spartanburg Nephrology Associates Spartanburg South Carolina

Sponsors (2)

Lead Sponsor Collaborator
USRC Kidney Research Akebia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality Time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality 9 months
Secondary Time to first hospitalization event reported as a serious adverse event (SAE) (excluding disease-related hospitalization [e.g., dialysis access placement, dialysis initiation, kidney transplant] and elective procedures) Time to first hospitalization event reported as a serious adverse event (SAE) (excluding disease-related hospitalization [e.g., dialysis access placement, dialysis initiation, kidney transplant] and elective procedures) 9 months
Secondary Component of Primary - Time to Initiation of Maintenance Dialysis Component of Primary - Time to Initiation of Maintenance Dialysis 9 months
Secondary Component of Primary - Time to All-Cause Mortality Component of Primary - Time to All-Cause Mortality 9 months
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