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Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

Primary Purpose

Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

ferric citrate

standard of care

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease focused on measuring Iron Deficiency Anemia, Non-Dialysis Dependent Chronic Kidney Disease, CKD, ferric citrate, pediatric, dialysis

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 6 years to <18 years at Screening
Body Weight ≥12 kilograms (kg) at Screening
Chronic kidney disease (CKD) stage 3 to 5, not on dialysis, with estimated glomerular filtration rate (eGFR) <60 milliliters per minute (mL/min)/1.73 meters squared (m^2) utilizing the "Bedside Schwartz" equation
Hemoglobin (Hgb) ≥8.5 and ≤11.5 grams per deciliter (g/dL) at Screening
Transferrin saturation (TSAT) ≤25% at Screening
Ferritin ≤200 nanograms per milliliter (ng/mL) at Screening

Exclusion Criteria:

Serum phosphorus level at Screening:
- 6 to <13 years: ≤4.0 milligrams per deciliter (mg/dL);
- 13 to <18 years: ≤2.7 mg/dL
Liver transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) ˃3× the upper limit of normal at Screening
Active significant gastrointestinal (GI) disorder, including overt gastrointestinal (GI) bleeding or active inflammatory bowel disease
Unable to swallow pills
Anemia due to causes other than iron deficiency anemia (IDA) of CKD
Intravenous iron therapy or blood transfusion within 4 weeks before the Screening visit
Participants with a functioning organ transplant
Receipt of any investigational drug within 4 weeks before Screening
Phosphate binder use during the Screening period

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferric citrate

Standard of care

Arm Description

Participants aged 12 to <18 years and 6 to <12 years will receive ferric citrate for 24 weeks at a starting dose based on body weight categories.

Participants aged 12 to <18 years and 6 to <12 years will receive standard of care treatment for 24 weeks.

Outcomes

Primary Outcome Measures

Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events

Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results

Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate

Secondary Outcome Measures

Change from Baseline in Hemoglobin to Week 24/Early Termination Visit

Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit

Change from Baseline in Ferritin to Week 24/Early Termination Visit

Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit

Change from Baseline in Calcium to Week 24/Early Termination Visit

Change from Baseline in Bicarbonate to Week 24/Early Termination Visit

Full Information

NCT ID

NCT04649411

First Posted

November 24, 2020

Last Updated

October 19, 2023

Sponsor

Keryx Biopharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT04649411

Brief Title

Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

Official Title

A 24-Week, Open-Label, Randomized, 2-Arm Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2025 (Anticipated)

Primary Completion Date

January 2027 (Anticipated)

Study Completion Date

March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Keryx Biopharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

Keywords

Iron Deficiency Anemia, Non-Dialysis Dependent Chronic Kidney Disease, CKD, ferric citrate, pediatric, dialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ferric citrate

Arm Type

Experimental

Arm Description

Participants aged 12 to <18 years and 6 to <12 years will receive ferric citrate for 24 weeks at a starting dose based on body weight categories.

Arm Title

Standard of care

Arm Type

Active Comparator

Arm Description

Participants aged 12 to <18 years and 6 to <12 years will receive standard of care treatment for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

ferric citrate

Other Intervention Name(s)

KRX-0502

Intervention Description

oral tablets

Intervention Type

Drug

Intervention Name(s)

standard of care

Intervention Description

administered per the approved label and at the Investigator's discretion

Primary Outcome Measure Information:

Title

Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events

Time Frame

up to Week 28

Title

Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results

Time Frame

up to Week 24

Title

Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate

Time Frame

up to Week 28

Secondary Outcome Measure Information:

Title

Change from Baseline in Hemoglobin to Week 24/Early Termination Visit

Time Frame

Baseline; Week 24

Title

Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit

Time Frame

Baseline; Week 24

Title

Change from Baseline in Ferritin to Week 24/Early Termination Visit

Time Frame

Baseline; Week 24

Title

Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit

Time Frame

Baseline; Week 24

Title

Change from Baseline in Calcium to Week 24/Early Termination Visit

Time Frame

Baseline; Week 24

Title

Change from Baseline in Bicarbonate to Week 24/Early Termination Visit

Time Frame

Baseline; Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 6 years to <18 years at Screening Body Weight ≥12 kilograms (kg) at Screening Chronic kidney disease (CKD) stage 3 to 5, not on dialysis, with estimated glomerular filtration rate (eGFR) <60 milliliters per minute (mL/min)/1.73 meters squared (m^2) utilizing the "Bedside Schwartz" equation Hemoglobin (Hgb) ≥8.5 and ≤11.5 grams per deciliter (g/dL) at Screening Transferrin saturation (TSAT) ≤25% at Screening Ferritin ≤200 nanograms per milliliter (ng/mL) at Screening Exclusion Criteria: Serum phosphorus level at Screening: 6 to <13 years: ≤4.0 milligrams per deciliter (mg/dL); 13 to <18 years: ≤2.7 mg/dL Liver transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) ˃3× the upper limit of normal at Screening Active significant gastrointestinal (GI) disorder, including overt gastrointestinal (GI) bleeding or active inflammatory bowel disease Unable to swallow pills Anemia due to causes other than iron deficiency anemia (IDA) of CKD Intravenous iron therapy or blood transfusion within 4 weeks before the Screening visit Participants with a functioning organ transplant Receipt of any investigational drug within 4 weeks before Screening Phosphate binder use during the Screening period

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Akebia Medical Information

Phone

844-445-3799

medicalinfo@akebia.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chief Medical Officer

Organizational Affiliation

Akebia Therapeutics Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

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