This is a pilot phase II study to evaluate the safety and efficacy of AND017 in NDD-CKD patients
This is a pilot phase 2, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral AND017 to treat anemia in non-dialysis-dependent chronic kidney disease patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
113
Amicis Research Center
Northridge, California, United States
Clinical Site Partners
Winter Park, Florida, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States
Elite Research Center
Flint, Michigan, United States
Safety Evaluations
Incidence of adverse events
Time frame: Up to 17 weeks
Rate of rise in hemoglobin for each of 3 dose levels as compared with placebo from baseline to 5 weeks after TIW oral dosing
Calculate the slope of a linear regression for each patient using all hemoglobin data collected during the Fixed-Dose Period
Time frame: Up to 5 weeks after dosing
Hb response to treatment during Period 1
Cumulative percentage of patients with Hb ≥10.0 g/dL
Time frame: Up to 5 weeks after dosing
Percentage of responder patients
Responder is defined as a hemoglobin ≥10.0 g/dL and an increase in hemoglobin by ≥1.0 g/dL
Time frame: Up to 13 weeks after dosing
Percentage of visits at which patients maintain hemoglobin between 10.0-11.0 g/dL after achieving hemoglobin ≥10.0 g/dL
Percentage of visits at which patients maintain hemoglobin between 10.0-11.0 g/dL after achieving hemoglobin ≥10.0 g/dL
Time frame: Up to 13 weeks after dosing
Change from baseline in Hb
Change from baseline in Hb
Time frame: Up to 13 weeks after dosing
Change in hemoglobin levels from baseline to the mean of weeks 10-13
Change in hemoglobin levels from baseline to the mean of weeks 10-13
Time frame: Baseline and at Week 10, 11, 12, 13, and 14
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Metrolina Nephrology Associates
Charlotte, North Carolina, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
Peking University People's Hospital
Beijing, Beijing Municipality, China
Percentage of patients who maintain hemoglobin between 10.0-11.0g/dL at each visit
Percentage of patients who maintain hemoglobin between 10.0-11.0g/dL at each visit
Time frame: Up to 13 weeks after dosing
Mean Hb levels at weeks 6-14 including the average of weeks 10-13
Mean Hb levels at weeks 6-14 including the average of weeks 10-13
Time frame: Up to 13 weeks after dosing
Cumulative incidence of lack of response over the entire treatment period
Hb level \< 10.0 g/dL and an increase in hemoglobin from baseline of \< 1 g/dL
Time frame: Up to13 weeks after dosing
To assess changes in the levels of PD indicator - EPO
To assess changes in the levels of EPO
Time frame: Baseline and at Week 2, 4, 6, 8, 10, 12, 14, and 28 days after the last dose
To assess changes in the levels of PD indicator - hepcidin
To assess changes in the levels of hepcidin
Time frame: Baseline and at Week 2, 4, 6, 8, 10, 12, 14, and 28 days after the last dose
To assess iron utilization parameter during treatment - transferrin level
To assess transferrin level during treatment
Time frame: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose
To assess iron utilization parameter during treatment - total iron-binding capacity (TIBC)
To assess TIBC level during treatment
Time frame: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose
To assess iron utilization parameter during treatment - transferrin saturation (TSAT)
To assess TSAT level during treatment
Time frame: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose
To assess iron utilization parameters during treatment - ferritin
To assess ferritin level during treatment
Time frame: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose
To assess iron utilization parameters during treatment - serum iron
To assess serum iron level during treatment
Time frame: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose