Clinical trial NCT03236246: KRX-0502 (Ferric Citrate) in Subjects With NDD-CKD and IDA (The COMPASS Trial)
Official title: Study of KRX-0502 (Ferric Citrate) Dose Regimens in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and Iron-Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Diseases
Iron Deficiency Anemia
Lead sponsor: Keryx Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to assess the long-term efficacy and safety of different dose regimens of KRX-0502 in the treatment of iron deficiency anemia (IDA) in adult subjects with non-dialysis dependent chronic kidney disease (CKD).

Detailed description: This is a Phase 4, 48-week, randomized, open-label, multicenter clinical study comprised of 2 periods: a 24-week Dose Titration Period, followed by a 24-week Dose Maintenance Period. The study will consist of 12 scheduled clinic visits over a period of 48 weeks and additional visits as needed.

Eligibility criteria: Inclusion Criteria:

* Estimated glomerular filtration rate ≥20 mL/min and \<60 mL/min
* Hgb ≥8.5 g/dL and ≤11.5 g/dL
* Serum ferritin ≤500 ng/mL and transferrin saturation (TSAT) ≤25%
* Serum intact parathyroid hormone ≤600 pg/mL

Exclusion Criteria:

* Serum phosphate \<3.0 mg/dL
* Intravenous (IV) iron administered within 4 weeks prior to Screening
* Erythropoiesis-stimulating agents (ESA) administered within 4 weeks prior to Screening
* Blood transfusion within 4 weeks prior to Screening

Primary outcomes:
measure: Change From Baseline in Hemoglobin (Hgb) at Week 24
timeFrame: Baseline; Week 24
Secondary outcomes:
measure: Change From Baseline in Hgb at Week 48
timeFrame: Baseline; Week 48
measure: Time From Randomization to the First Increase From Baseline Hgb of at Least 0.5 Grams Per Deciliter (g/dL) During the Dose Titration Period
timeFrame: from Randomization to Week 24
measure: Change From Baseline in Transferrin Saturation (TSAT) at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in TSAT at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in Ferritin at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in Ferritin at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in Serum Phosphate at Week 24
timeFrame: Baseline; up to Week 24
measure: Change From Baseline in Serum Phosphate at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in eGFR at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in Bicarbonate at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in Bicarbonate at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in Intact Parathyroid Hormone (iPTH) at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in iPTH at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in C-terminal Fibroblast Growth Factor 23 (FGF23) at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in C-terminal FGF23 at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in Intact Fibroblast Growth Factor 23 at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline Scores for the Work Productivity and Activity Impairment (WPAI) Questionnaire Adapted for Anemia Associated With Chronic Kidney Disease (CKD) at Week 24: Work-associated Measures
timeFrame: Baseline; Week 24
measure: Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Work-associated Measures
timeFrame: Baseline; Week 48
measure: Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 24: Activity Impairment
timeFrame: Baseline; Week 24
measure: Change From Baseline Scores for the WPAI Questionnaire Adapted for Anemia Associated With CKD at Week 48: Activity Impairment
timeFrame: Baseline; Week 48
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Score at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue Scale Score at Week 48
timeFrame: Baseline; Week 48
measure: Number of Hospitalizations for Participants Who Entered the Dose Maintenance Period
timeFrame: up to Week 48
measure: Duration of Hospitalizations for Participants Who Entered the Dose Maintenance Period
timeFrame: up to Week 48
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) for Participants Who Entered the Dose Maintenance Period
timeFrame: up to Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Kidney Disease and Hypertension center: AKDHC Medical Research Services, LLC
state: Arizona
city: Chula Vista
country: United States
facility: California Institute of Renal Research
state: California
city: El Centro
country: United States
facility: California Institute of Renal Research
state: California
city: Poway
country: United States
facility: California Institute of Renal Research
state: California
city: Denver
country: United States
facility: Denver Nephrologists, P.C.
state: Colorado
city: Miami
country: United States
facility: Miami Kidney Group
state: Florida
city: Miami
country: United States
facility: Kidney and Hypertension Specialists of Miami, P.A.
state: Florida
city: Augusta
country: United States
facility: Southeastern Clinical Research Institute, LLC
state: Georgia
city: Columbus
country: United States
facility: Renal Associates, LLC
state: Georgia
city: Chicago
country: United States
facility: Research by Design, LLC
state: Illinois
city: Gulfport
country: United States
facility: South Mississippi Medical Research, LLC
state: Mississippi
city: Kansas City
country: United States
facility: Clinical Research Consultants
state: Missouri
city: Reno
country: United States
facility: Sierra Nevada Nephrology Consultants
state: Nevada
city: Eatontown
country: United States
facility: Hypertension and Nephrology Association
state: New Jersey
city: Great Neck
country: United States
facility: Division of Kidney/HTN Research
state: New York
city: Asheville
country: United States
facility: Mountain Kidney & Hypertension Associates
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Nephrology Associates, PA
state: North Carolina
city: Greenville
country: United States
facility: Eastern Nephrology Associates
state: North Carolina
city: Jacksonville
country: United States
facility: Southeastern Nephrology Associates
state: North Carolina
city: New Bern
country: United States
facility: Eastern Nephrology Associates
state: North Carolina
city: Wilmington
country: United States
facility: Southeastern Nephrology
state: North Carolina
city: Columbia
country: United States
facility: Columbia Nephrology Associates, PA
state: South Carolina
city: Orangeburg
country: United States
facility: South Carolina Nephrology & Hypertension Center, Inc
state: South Carolina
city: Nashville
country: United States
facility: Nephrology Associates, P.C.
state: Tennessee
city: Austin
country: United States
facility: Research Management, Inc.
state: Texas
city: Austin
country: United States
facility: Research Management, Inc.
state: Texas
city: Lufkin
country: United States
facility: P & I Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
Study officials:
affiliation: Keryx Biopharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References: