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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05035641
Other study ID # AND017-MN-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 18, 2021
Est. completion date July 24, 2023

Study information

Verified date October 2023
Source Kind Pharmaceuticals LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot phase II study to evaluate the safety and efficacy of AND017 in NDD-CKD patients


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date July 24, 2023
Est. primary completion date July 5, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 74 Years
Eligibility Key Inclusion Criteria: 1. Diagnosis of chronic kidney disease, not receiving dialysis, with an eGFR <60 mL/min/1.73 m2. 2. Baseline Hb level = 7.5 g/dL and <10.0 g/dL. 3. TSAT = 20% or ferritin = 100 ng/mL at screening test 4. Serum folate and vitamin B12 = lower limit of normal at screening test 5. AST and ALT = 3×ULN. 6. Total bilirubin = 1.5×ULN. Key Exclusion Criteria: 1. Concurrent retinal neovascular lesions requiring treatment including proliferative diabetic retinopathy, exudative age-related macular degeneration, retinal vein occlusion, macular edema, etc. 2. Anemia that is possibly mainly caused by concurrent autoimmune disease with inflammatory symptoms 3. History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent symptomatic gastroparesis despite being on treatment. 4. Clinically significant bleeding (eg, requiring transfusion or drop in Hb of = 2g/dL) within 4 weeks of first dose; no bleeding diathesis or risk of bleeding that has not been medically or surgically corrected at least 4 weeks prior to first dose of study drug. 5. Uncontrolled hypertension defined as patients with hypertension having more than one of three diastolic blood pressure values >95 mmHg and each test at least 5 min apart during the screening assessment. 6. Concurrent congestive heart failure (New York Heart Association [NYHA] Class III or higher). 7. History of stroke, transient ischemic attack, myocardial infarction, thromboembolic event, pulmonary embolism, or lung infarction within 24 weeks before the screening assessment. 8. Concurrent anemia due to another cause other than renal anemia 9. Known hemosiderosis, hemochromatosis or hyper-coagulable condition 10. Any treatment with a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) within 5 weeks before randomization. 11. Having received treatment with erythropoiesis stimulating agents, androgenic anabolic steroids, testosterone enanthate, or mepitiostane within 5 weeks before the first dose. 12. Total bilirubin >1.5xULN, or AST>3xULN, or ALT>3xULN, or ALP>3xULN, or previous or concurrent serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.) thought to be caused by ESAs. 13. Patients with a history of significant liver disease or active liver disease. Investigators should discuss this with the Medical Monitor for cases where there is doubt about whether to exclude or not. 13. Patients that have major surgery planned during the study period. 14. Having undergone blood transfusion and/or a surgical procedure within 8 weeks before the screening assessment. 15. Having undergone a kidney transplantation. 16. History of a seizure disorder or any occurrence of seizures in the past

Study Design


Intervention

Drug:
AND017
Orally, 3 times per week in Period 1 and randomize to TIW or QW group at the same dose in Period 2
Placebo
Orally, 3 times per week

Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing
United States Metrolina Nephrology Associates Charlotte North Carolina
United States Southeast Renal Research Institute Chattanooga Tennessee
United States Elite Research Center Flint Michigan
United States Amicis Research Center Northridge California
United States Clinical Advancement Center, PLLC San Antonio Texas
United States Northwest Louisiana Nephrology Shreveport Louisiana
United States Clinical Site Partners Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Kind Pharmaceuticals LLC

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Evaluations Incidence of adverse events Up to 17 weeks
Primary 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 Up to 5 weeks after dosing
Secondary Hb response to treatment during Period 1 Cumulative percentage of patients with Hb =10.0 g/dL Up to 5 weeks after dosing
Secondary Percentage of responder patients Responder is defined as a hemoglobin =10.0 g/dL and an increase in hemoglobin by =1.0 g/dL Up to 13 weeks after dosing
Secondary 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 Up to 13 weeks after dosing
Secondary Change from baseline in Hb Change from baseline in Hb Up to 13 weeks after dosing
Secondary 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 Baseline and at Week 10, 11, 12, 13, and 14
Secondary 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 Up to 13 weeks after dosing
Secondary 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 Up to 13 weeks after dosing
Secondary 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 Up to13 weeks after dosing
Secondary To assess changes in the levels of PD indicator - EPO To assess changes in the levels of EPO Baseline and at Week 2, 4, 6, 8, 10, 12, 14, and 28 days after the last dose
Secondary To assess changes in the levels of PD indicator - hepcidin To assess changes in the levels of hepcidin Baseline and at Week 2, 4, 6, 8, 10, 12, 14, and 28 days after the last dose
Secondary To assess iron utilization parameter during treatment - transferrin level To assess transferrin level during treatment Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose
Secondary To assess iron utilization parameter during treatment - total iron-binding capacity (TIBC) To assess TIBC level during treatment Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose
Secondary To assess iron utilization parameter during treatment - transferrin saturation (TSAT) To assess TSAT level during treatment Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose
Secondary To assess iron utilization parameters during treatment - ferritin To assess ferritin level during treatment Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose
Secondary To assess iron utilization parameters during treatment - serum iron To assess serum iron level during treatment Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose
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