NCT01596855

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on maintenance hemodialysis and receiving epoetin alfa.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 4, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

April 30, 2012

Last Update Submit

January 31, 2013

Conditions

Anemia in End Stage Renal Disease

Keywords

AnemiaRenal

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7.

    Week 7

Secondary Outcomes (2)

  • Number (%) of subjects whose hemoglobin levels are between 9.0 and 13.0 g/dL at Weeks 3, 4, 5, 6 and 7.

    Week 7

  • Number (%) of subjects whose hemoglobin levels at Weeks 3, 4, 5, 6 and 7 are greater than or equal to their baseline level.

    Week 7

Study Arms (2)

FG-4592

EXPERIMENTAL

Active Drug

Drug: FG-4592

Epoetin alfa

ACTIVE COMPARATOR

Standard of care

Drug: Epoetin Alfa

Interventions

FG-4592DRUG

TIW dosing, capsule

FG-4592
Epoetin AlfaDRUG

TIW

Epoetin alfa

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has voluntarily signed and dated an informed consent form
  • Age 18 to 75 years
  • End-stage renal disease (ESRD) and receiving maintenance hemodialysis TIW for ≥4 months prior to Day 1
  • Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be between 9.0 and 12.0 g/dL (inclusive), and the difference between them must be ≤1.5 g/dL.
  • Stable doses of IV or Subcutaneous injection of epoetin alfa, defined as follows:
  • Epoetin alfa dose range for 6 weeks prior to Day -7:
  • to 20,000 IU/week
  • Stable doses of epoetin alfa (i.e., the maximum epoetin alfa dose does not exceed 130% of the lowest dose of epoetin alfa taken in this period)
  • Complete Blood Count (CBC), Hematology, liver function blood tests within acceptable limits
  • Serum folate and vitamin B12 levels above the lower limit of normal (LLN)
  • Body weight: 40 to 100 kg (dry weight) inclusive
  • Body mass index (BMI): 16 to 38 kg/m2 inclusive
  • HD subjects: dialysis vascular access via native arteriovenous fistula or synthetic graft (not via catheter)

You may not qualify if:

  • Anticipated change in hemodialysis prescription or access during the screening or dosing period of the study
  • Any clinically significant infection or evidence of an underlying infection such as a white blood cell count (WBC) \> ULN during screening on two separate occasions,
  • Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab)
  • History of chronic liver disease
  • New York Heart Association Class III or IV congestive heart failure
  • Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
  • Active or chronic gastrointestinal bleeding, or a known coagulation disorder
  • Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)
  • Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
  • History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric
  • Active hemolysis or diagnosis of hemolytic syndrome
  • Known bone marrow fibrosis
  • Uncontrolled or symptomatic secondary hyperparathyroidism (PTH\>600ng/L)
  • Any prior organ transplantation
  • Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Peking Union Medical College Hospital

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, China

Location

Zhejiang University No 1. Hospital

Hangzhou, China

Location

Chang Zheng Hospital

Shanghai, China

Location

Renji Hospital

Shanghai, China

Location

RuiJin Hospital

Shanghai, China

Location

XinHua Hospital

Shanghai, China

Location

ShenZhen People's Hospital

Shenzhen, China

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: 36005278DERIVED

MeSH Terms

Conditions

Anemia

Interventions

roxadustatEpoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

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

April 30, 2012

First Posted

May 11, 2012

Study Start

September 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 4, 2013

Record last verified: 2013-01

Locations

CN(9)