CKD Anemia in Dialysis Participants
Conditions
Keywords
Anemia, Chronic Kidney Disease Dialysis, hemoglobin, End stage renal disease
Brief summary
This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period. There are 3 study periods: * Screening Period (up to 4 weeks) * Treatment Period (36 weeks) Part 1: Correction/Conversion Period (Weeks 1-20) Part 2: Hemoglobin (Hb) Maintenance Period (Weeks 21-36) * Follow-up Period (4 weeks)
Detailed description
Approximately 102 erythropoiesis stimulating agents (ESA)-naïve participants and 204 ESA-treated participants will be enrolled and randomized respectively in a 1:1 ratio to receive roxadustat at one of 2 starting doses as below: * Low weight-based dosing: 70 milligrams (mg) 3 times a week (TIW) for body weight \<60 kilograms (kg) or 100 mg TIW for body weight ≥60 kg * Standard weight-based dosing: 100 mg TIW for body weight \<60 kg or 120 mg TIW for body weight ≥60 kg After 20 weeks of treatment, all eligible participants whose last 2 Hb levels ≥105 grams (g)/liter (L) and change in Hb over the most recent 4 weeks is \> - 10 g/L will switch to receive roxadustat for another 16 weeks to evaluate the efficacy and safety of new dosing regimens. At the end of Week 36, all participants will discontinue roxadustat and enter a 4-week Follow-up Period.
Interventions
DRUGRoxadustat
Roxadustat will be dosed orally per dose and schedule specified in the arm description.
Sponsors
Kyntra Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1\. CKD with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)
Exclusion criteria
1. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab). 2. Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (for example, deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day 1. 3. History of malignancy, myelodysplastic syndrome, and multiple myeloma. 4. Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (for example, systemic lupus erythematosis \[SLE\], rheumatoid arthritis, celiac disease). 5. Clinically significant gastrointestinal bleeding. 6. Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits | Weeks 33 to 37 |
| Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks | Weeks 1 to 20 |
| Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits | Weeks 17 to 21 |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits | Baseline, Weeks 17 to 21 |
| Part 1 (ESA-Naïve): Percentage of Participants With Mean Hb (Averaged Weeks 17 to 21 Visits) ≥100 g/L | Weeks 17 to 21 |
| Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L | Weeks 33 to 37 |
Countries
China
Outcome results
None listed