Brief Summary

This is a randomized, multicenter, open-label, active-controlled study of the treatment of anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.

Trial Health

On Track

Trial Health Score

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

Enrollment

305

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2015

Geographic Reach

1 country

31 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

1.5 years study duration

Study Start

First participant enrolled

December 1, 2015

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2015

Completed

12 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2017

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed

Last Updated

August 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

December 31, 2015

Last Update Submit

August 23, 2017

Conditions

Anemia

Keywords

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

Hb mean change from baseline
Hb mean change from baseline
Weeks 23 to 27.

Secondary Outcomes (13)

Mean change from baseline in low-density lipoprotein (LDL) cholesterol
Weeks 25-27
Number of subjects with a Hb response
Weeks 23-27
Percent of subjects with a Hb response
Weeks 23-27
Effect on iron metabolism
Week 27
Proportion of subjects with exacerbation of hypertension
Up to Week 27
+8 more secondary outcomes

Study Arms (2)

FG-4592

EXPERIMENTAL

Intervention is investigational treatment FG-4592

Drug: FG-4592

EPO

ACTIVE COMPARATOR

Intervention is subject's current dose of Li Xue Bao (epoetin alfa)

Drug: Epoetin Alfa

Interventions

FG-4592DRUG

FG-4592

Epoetin AlfaDRUG

Also known as: Li Xue Bao

EPO

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ages 18 to 75 years
Subject has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC), after the nature of the study has been explained and the subject has had the opportunity to ask questions; a separate ICF is needed for subjects participating in the PK Sub-study.
"Chronic kidney disease with end-stage renal disease (ESRD) on either adequate hemodialysis (HD) or adequate peritoneal dialysis for a minimum of 16 weeks prior to Day 1: For subjects undergoing HD, the vascular access must be via native arteriovenous (AV) fistula or graft, or permanent, tunneled catheter."
Subjects must be on stable doses of IV or subcutaneous (SC) injections of epoetin alfa for at least 6 weeks prior to Day 1 (average dose ≤15,000 IU/week)
Mean of the two most recent central laboratory Hb values during the Screening Period, obtained at least 6 days apart, must be 9.0 g/dL to 12.0 g/dL, inclusive, with a difference of \\≤1.5 g/dL between the highest and the lowest Hb values.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 x upper limit of normal (ULN), and normal total bilirubin at screening visit except for subjects with Gilberts syndrome (based on central laboratory results).
Body weight: 45 to 100 kg inclusive 8 Subjects agree not to start taking any new Traditional Chinese Medicine (TCM) for anemia and not to change dose, schedule, or brand of any prescreening TCM for anemia from beginning of Screening Period through end of Follow-up Period.

You may not qualify if:

Any clinically significant infection or evidence of an active underlying infection.
Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
Chronic liver disease.
New York Heart Association Class III or IV congestive heart failure.
Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (eg, deep venous thrombosis or pulmonary embolism) within 52 weeks prior to Day 1.
Uncontrolled hypertension in the opinion of the investigator (eg, that requires change in anti-hypertensive medication within 2 weeks prior to randomization).
Diagnosis or suspicion (eg, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma as shown on screening renal ultrasound.
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, or in situ cancer at any site.
Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (eg, systemic lupus erythematosis \[SLE\], rheumatoid arthritis, celiac disease).
Clinically significant gastrointestinal bleeding.
Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition.
Any prior functioning organ transplant or a scheduled organ transplantation, or anephric.
Anticipated elective surgery that could lead to significant blood loss during the study period.
Anticipated use of dapsone or acetaminophen (paracetamol) \>2.0 g/day, or \>500 mg per dose repeated every 6 hours for more than 3 days.
Serum albumin \<2.5 g/dL.
+11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Kyntra Biolead

Study Sites (31)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

301 Hospital