Study of Roxadustat (FG-4592) to Correct Anemia in Newly Initiated Dialysis Participants Not on Erythropoiesis-Stimulating Agent Treatment

NCT01414075 | Completed Phase 2 Results DMC

• 1 other identifier: FGCL-4592-053
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 7

Brief Summary

The purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with end-stage renal disease who recently started dialysis.

Conditions

Dialysis; Anemia

Keywords

Kidney; ESRD; Renal; End-Stage Renal Disease; Anemia; Oral anemia treatment; Hemoglobin levels; Hemodialysis; Peritoneal; HD; PD; Hb; Erythropoietin; Blood count

Outcome Measures

Primary Outcomes (1)

• Maximum Change From Baseline in Hb During Weeks 3-13

  Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation.

  Baseline, Weeks 3-13

Secondary Outcomes (25)

• Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13

  Baseline, Weeks 2-5, 6-9, and 10-13

• Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL

  Week 3 to 13

• Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL

  Week 3 to 13

• Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13

  Weeks 5, 9, and 13

• Number of Participants Who Achieved Maximum Hb During Weeks 3-13

  Weeks 3-13

Study Arms (4)

Arm A + E (Participants on HD): Roxadustat Only, No Iron

EXPERIMENTAL

Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally 3 times weekly (TIW) for 12 weeks.

Drug: Roxadustat

Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg

EXPERIMENTAL

Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.

Drug: Roxadustat; Drug: Oral Iron

Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg

EXPERIMENTAL

Participants on HD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with approximately 60 mg IV iron (ferric gluconate complex in sucrose injection \[for example, Ferrlecit®\] or equivalent) once a week for 12 weeks.

Drug: Roxadustat; Drug: IV Iron

Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg

EXPERIMENTAL

Participants on PD will receive roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW with iron (ferrous fumarate or ferrous gluconate) PO at doses containing elemental iron between 50 and 195 mg daily (depending on the type of iron formulation available in their countries) for 12 weeks.

Drug: Roxadustat; Drug: Oral Iron

Interventions

Roxadustat DRUG

Tiered, weight-based dosing per schedule specified in the arm.

Also known as: FG-4592

Arm A + E (Participants on HD): Roxadustat Only, No Iron; Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg; Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg; Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg

Oral Iron DRUG

Administered per oral dose and schedule specified in the arm.

Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg; Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg

IV Iron DRUG

Administered per IV dose and schedule specified in the arm.

Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving HD or PD for native kidney end-stage renal disease (ESRD) for 2 weeks to 4 months, prior to randomization
• Mean of the 2 most recent Hb values during the screening period, obtained at least 7 days apart, must be \<10.0 grams (g)/deciliter (dL), with a difference of ≤1.0 g/dL between the 2 values
• Body weight 40 to 140 kilograms (kg)

You may not qualify if:

• Previously received erythropoiesis-stimulating agents
• Received IV iron within 4 weeks of randomization
• Received red blood cell transfusion within 8 weeks prior to randomization or anticipated need for transfusion during the treatment period
• Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
• History of chronic liver disease
• Clinically significant infection
• New York Heart Association Class III or IV congestive heart failure
• History of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
• Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
• History of other blood disorders
• Active hemolysis or diagnosis of hemolytic syndrome
• Known bone marrow fibrosis
• Uncontrolled or symptomatic secondary hyperparathyroidism
• History of alcohol or drug abuse within a year prior to randomization, or anticipated inability to avoid consumption of more than 3 alcoholic beverages per day
• History of allergy or sensitivity to oral or IV iron therapy

Sponsors & Collaborators

• Kyntra Bio: lead
• Astellas Pharma Inc: collaborator

Study Sites (7)

Unknown Facility

Northridge, California, United States

Location

Unknown Facility

Yuba City, California, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Singapore, Singapore

Location

Related Publications (1)

• Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

  PMID: 36005278 DERIVED

MeSH Terms

Conditions

Anemia; Kidney Failure, Chronic

Interventions

roxadustat; Iron; ferryl iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Results Point of Contact

• Title: Clinical Trial Information Desk
• Organization: FibroGen, Inc.

415-978-1441

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 11, 2011
• Study Start: July 21, 2011
• Primary Completion: January 10, 2013
• Study Completion: January 10, 2013
• Last Updated: October 1, 2021
• Results First Posted: October 1, 2021

Record last verified: 2021-09

Locations

SG (1); US (3); RU (2); HK (1)