Anemia in Chronic Kidney Disease
Conditions
Keywords
Anemia, Renal
Brief summary
The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in non-dialysis chronic kidney disease patients.
Detailed description
Dose ranging study with two consecutive dose escalation cohorts. The study objective is to demonstrate that FG-4592 is effective in the correction of anemia in chronic kidney disease patients.
Interventions
DRUGFG-4592
TIW dosing, capsule
DRUGPlacebo
TIW dosing, capsule
Sponsors
Kyntra Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 75 years 2. Subject has voluntarily signed and dated an informed consent form 3. Chronic Kidney Disease, not receiving dialysis 4. Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be \<10g/dL 5. Aminotransferase levels (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]) and total bilirubin must be ≤ upper limit of normal (ULN) during the screening period 6. Serum alkaline phosphatase (ALP) ≤2x ULN during screening period. Subjects with serum ALP values between 1 x and 2 x ULN may be included only if bone-specific ALP (BSAP) is also elevated \> ULN 7. Total bilirubin values must be ≤ULN during screening period 8. Serum folate and vitamin B12 levels above the lower limit of normal (LLN) 9. Body weight: 40 to 100 kg (dry weight) inclusive 10. Body mass index (BMI): 16 to 38 kg/m2 inclusive
Exclusion criteria
1. Received any erythropoiesis-stimulating agent (ESA) other than epoetin alfa within 12 weeks prior to Day 1 2. 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, 3. Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab) 4. History of chronic liver disease 5. New York Heart Association Class III or IV congestive heart failure 6. 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 7. Active or chronic gastrointestinal bleeding, or a known coagulation disorder 8. Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.) 9. Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia 10. History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric 11. Active hemolysis or diagnosis of hemolytic syndrome 12. Known bone marrow fibrosis 13. Uncontrolled or symptomatic secondary hyperparathyroidism (PTH\>600ng/L) 14. Any prior organ transplantation 15. Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug 16. Serum albumin \<3 g/dL 17. History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject 18. Prior treatment with FG-4592 19. Use of an investigational medication or treatment, or carryover effect of an investigational treatment expected, during the screening visit, treatment and follow-up period. 20. Use of traditional Chinese medicines (TCM) during the screening visit to Day 1 or plans to use TCM during the study unless approved in advance by the Medical Monitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum change in hemoglobin by Week 9 from baseline | Week 9 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a target Hb level ≥11 g/dL by Weeks 5,6,7,8 and 9. | Week 9 |
| Proportion of subjects with a Hb increase from baseline ≥1.0 g/dL. | Week 9 |
Countries
China
Outcome results
None listed