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COMPLETEDPHASE2

A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients

A Pilot Phase II Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral AND017 to Treat Anemia in Nondialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients

NCT05035641•Kind Pharmaceuticals LLC

View on ClinicalTrials.gov

Summary

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

Detailed 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.

Eligibility

Age

20 - 74 years

Sex

ALL

Healthy Volunteers

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.

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.
+5 more criteria

Locations (8)

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

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

Key Dates

Start Date

October 18, 2021

Primary Completion Date

July 5, 2023

Completion Date

July 24, 2023

Last Updated

October 4, 2023

Enrollment

113

ACTUAL participants

Conditions

Renal Anemia

Interventions

AND017

DRUG

Placebo

DRUG

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COMPLETED

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients

Inclusion Criteria

Exclusion Criteria

Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease

Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia

A Study to Investigate the Effect of ASP1517 After Intermittent Oral Dosing in Dialysis Chronic Kidney Disease Patients With Anemia Compared With Darbepoetin as a Reference Drug

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