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

NCT ID: NCT05035641

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2023-07-24

Brief 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.

Conditions

Renal Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AND017 Dose A

AND017 will be administrated orally at dose A

Group Type: EXPERIMENTAL

AND017

Intervention Type: DRUG

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

AND017 Dose B

AND017 will be administrated orally at dose B

Group Type: EXPERIMENTAL

AND017

Intervention Type: DRUG

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

AND017 Dose C

AND017 will be administrated orally at dose C

Group Type: EXPERIMENTAL

AND017

Intervention Type: DRUG

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

Placebo

Placebo will be administrated orally

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Orally, 3 times per week

Interventions

AND017

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

Intervention Type: DRUG

Placebo

Orally, 3 times per week

Intervention Type: DRUG

Eligibility Criteria

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.

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kind Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yusha Zhu, MD PhD

Role: STUDY_DIRECTOR

Kind Pharmaceuticals LLC

Locations

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

Countries

United States; China

Other Identifiers

AND017-MN-201

Identifier Type: -

Identifier Source: org_study_id