A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis

NCT ID: NCT05265325

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2024-04-25

Brief Summary

This is a phase II study to evaluate the safety and efficacy of AND017 in renal anemia patients on dialysis

Detailed Description

This is a Phase II study to assess the safety and efficacy of AND017 in patients with CKD who are anemic and on dialysis.

Conditions

Renal Anemia

Study Design

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

Study Groups

AND017 Dose Regimen A

AND017 will be administrated orally at dose A three times a week

Group Type: EXPERIMENTAL

AND017 capsules TIW

Intervention Type: DRUG

Orally, 3 times per week in Period 1 and dose adjustment in Period 2 at 2 mg/4 mg and 2-weeks interval according to Hb levels

AND017 Dose Regimen B

AND017 will be administrated orally at dose B once a week

Group Type: EXPERIMENTAL

AND017 capsules QW

Intervention Type: DRUG

Orally, once per week in Period 1 and dose adjustment in Period 2 at 4 mg/8 mg and 2-weeks interval according to Hb levels

Erythropoietin stimulating agent

Investigator will select an erythropoietin stimulating agent, such as epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars, for the patient under this arm with starting doses and dose adjustment rules according to the epoetin alfa USPI or SmPC.

Group Type: ACTIVE_COMPARATOR

epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars

Intervention Type: DRUG

Dose regimen and adjustment rules according to the USPI or SmPC or local practice

Interventions

AND017 capsules TIW

Orally, 3 times per week in Period 1 and dose adjustment in Period 2 at 2 mg/4 mg and 2-weeks interval according to Hb levels

Intervention Type: DRUG

AND017 capsules QW

Orally, once per week in Period 1 and dose adjustment in Period 2 at 4 mg/8 mg and 2-weeks interval according to Hb levels

Intervention Type: DRUG

epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars

Dose regimen and adjustment rules according to the USPI or SmPC or local practice

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Body weight from 45 to 140 kg inclusive

2. Receiving stable HD (including combination methods such as hemodiafiltration or hemofiltration), HHD, or PD for ESKD for a minimum of 16 weeks prior to randomization and determined by the Investigator to be compliant with dialysis treatment prescription.

3. Patient must have been on IV or SC of an approved ESA under the prescription for at least 6 weeks, and ≤25% change in dose between the two most recent doses, prior to randomization.

4. The mean of two hemoglobin values during screening (at least 7 days apart) must be 9.0-11.0 g/dL with a difference of ≤1.3 g/dL between the two values

5. TSAT ≥ 20% or ferritin ≥ 100 ng/mL at screening

6. Folate ≥ 3.0 ng/mL and vitamin B12 ≥ lower limit of normal (LLN) at screening

7. AST and ALT < 3×ULN at screening.

8. No evidence of other causes of anemia caused by a pathologic process in the hematopoietic system, including intra- or extravascular hemolysis, or myelodysplasia.

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 determined by the Investigator to be caused by concurrent autoimmune disease with inflammatory symptoms (such as systemic erythematosus, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, Sjögren's syndrome, celiac disease, etc.).

3. History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent symptomatic gastroparesis despite on treatment.

4. Clinically significant bleeding (eg, requiring transfusion or drop in Hb of ≥ 2 g/dL) within 4 weeks of first dose; 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 (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.

8. Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody at the screening assessment, or positive for human immunodeficiency virus in a past test.

9. Not complying with COVID-19 prevention and control requirements per local policy.

10. Concurrent primary form of anemia other than renal anemia (hemolytic anemia, thalassemia, sickle cell anemia, history of pure red cell aplasia, history of myelodysplastic syndrome or multiple myeloma, iron deficiency, etc.). Any question of the primary cause of anemia should be discussed with the Medical Monitor before the patient signs informed consent.

11. Known hemosiderosis, hemochromatosis or hyper-coagulable condition

12. Known to be hypersensitive or intolerant to ESA.

13. Having received treatment with androgenic anabolic steroids, testosterone enanthate, or mepitiostane within 5 weeks prior to the first dose.

14. Any treatment with a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) within 5 weeks prior to the first dose.

15. TBIL>1.5 ULN, or AST>3 ULN, or ALT>3 ULN, or ALP>3 ULN, or previous or concurrent serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.) thought to be caused by any other HIF-PHI.

16. Previous or current malignant tumor (patients with no recurrence for at least 5 years are eligible. Exemption: basal cell and squamous cell carcinoma not under active stage).

17. Patients with a history of significant liver disease or active liver disease.

18. Patients that have major surgery planned during the study period.

19. Patients that have undergone blood transfusion or with evidence of major blood loss within 8 weeks before the screening assessment. Investigators should discuss this with the Medical Monitor for cases where there is doubt about whether to exclude or not.

20. Patients unable to discontinue IV iron during the screening period.

21. Patients with an organ transplant on immunosuppression, or with a scheduled kidney or any other organ transplant within the duration of the study, or without kidney.

22. Serum albumin < 2.5 g/dL at screening.

23. Patients with other chronic medical condition that may limit life expectancy in the opinion of the Investigator.

24. History of a seizure disorder or any occurrence of seizures in the past.

• Minimum Eligible Age: 18 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

US Renal Care - Pine Bluff

Pine Bluff, Arkansas, United States

North America Research Institute

Riverside, California, United States

Rocky Mountain Kidney Care

Lone Tree, Colorado, United States

Nephrology and Hypertension Specialists

Dalton, Georgia, United States

High Desert Nephrology Associates

Gallup, New Mexico, United States

Nephrology Associates of Western New York

Cheektowaga, New York, United States

Nephrology Consultants of Northwest Ohio - Toledo

Toledo, Ohio, United States

South Texas Renal Care Group - San Saba

San Antonio, Texas, United States

Clinical Advancement Center PLLC

San Antonio, Texas, United States

South Texas Renal Care Group

San Antonio, Texas, United States

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Xiamen Branch, Zhongshan hospital affilicated to Fudan University

Xiamen, Fujian, China

Xiamen Fifth Hospital

Xiamen, Fujian, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Renmin Hospital of Wuhan University

Wuhan, Hunan, China

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Jinshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Zigong First People's Hospital

Zigong, Sichuan, China

Countries

United States; China

Other Identifiers

AND017-MN-202

Identifier Type: -

Identifier Source: org_study_id