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

NCT05265325 | Completed Phase 2 FDA Drug

• 1 other identifier: AND017-MN-202
• Study Type: interventional
• Target: 175
• Locations: 2 countries
• Sites: 25

Brief Summary

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

Conditions

Renal Anemia

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Incidence of adverse events

  Up to 20 weeks

• Mean change from baseline in Hb at Week 6

  Mean change from baseline in Hb at Week 6

  Up to 5 weeks after dosing

Secondary Outcomes (6)

• Proportion of responders, during the entire study period.

  up to Week 20

• Mean proportion of visits at which patients maintain Hb within the target range from baseline during the fixed-dose period and titration period

  up to Week 20

• Proportion of patients with a mean Hb between 10.0-11.0 g/dL inclusive during Week 14-20

  at Week 14, 15, 16, 17, 18, 19, and 20

• Change in Hb from baseline to the mean Hb levels over Week 14-20

  Baseline and at Week 14, 15, 16, 17, 18, 19, and 20

• Mean Hb levels and mean change from baseline in Hb level at each visit

  up to Week 20

Other Outcomes (3)

• EPO levels and change from baseline at each visit

  up to Week 20

• Hepcidin levels and change from baseline at each visit

  up to Week 20

• Iron study levels and change from baseline at each visit

  up to Week 20

Study Arms (3)

AND017 Dose Regimen A

EXPERIMENTAL

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

Drug: AND017 capsules TIW

AND017 Dose Regimen B

EXPERIMENTAL

AND017 will be administrated orally at dose B once a week

Drug: AND017 capsules QW

Erythropoietin stimulating agent

ACTIVE COMPARATOR

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.

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

Interventions

AND017 capsules TIW 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 A

AND017 capsules QW 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

AND017 Dose Regimen B

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

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

Erythropoietin stimulating agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body weight from 45 to 140 kg inclusive
• 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.
• 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.
• 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
• TSAT ≥ 20% or ferritin ≥ 100 ng/mL at screening
• Folate ≥ 3.0 ng/mL and vitamin B12 ≥ lower limit of normal (LLN) at screening
• AST and ALT \< 3×ULN at screening.
• No evidence of other causes of anemia caused by a pathologic process in the hematopoietic system, including intra- or extravascular hemolysis, or myelodysplasia.

You may not qualify if:

• Concurrent retinal neovascular lesions requiring treatment including proliferative diabetic retinopathy, exudative age-related macular degeneration, retinal vein occlusion, macular edema, etc.
• 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.).
• 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.
• 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.
• 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.
• Concurrent congestive heart failure (New York Heart Association \[NYHA\] Class III or higher).
• 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.
• 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.
• Not complying with COVID-19 prevention and control requirements per local policy.
• 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.
• Known hemosiderosis, hemochromatosis or hyper-coagulable condition
• Known to be hypersensitive or intolerant to ESA.
• Having received treatment with androgenic anabolic steroids, testosterone enanthate, or mepitiostane within 5 weeks prior to the first dose.
• Any treatment with a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) within 5 weeks prior to the first dose.
• 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.

Sponsors & Collaborators

• Kind Pharmaceuticals LLC: lead

Study Sites (25)

US Renal Care - Pine Bluff

Pine Bluff, Arkansas, 71603, United States

Location

North America Research Institute

Riverside, California, 92503, United States

Location

Rocky Mountain Kidney Care

Lone Tree, Colorado, 80124, United States

Location

Nephrology and Hypertension Specialists

Dalton, Georgia, 30720, United States

Location

High Desert Nephrology Associates

Gallup, New Mexico, 87301, United States

Location

Nephrology Associates of Western New York

Cheektowaga, New York, 14225, United States

Location

Nephrology Consultants of Northwest Ohio - Toledo

Toledo, Ohio, 43613, United States

Location

South Texas Renal Care Group - San Saba

San Antonio, Texas, 78207, United States

Location

Clinical Advancement Center PLLC

San Antonio, Texas, 78212, United States

Location

South Texas Renal Care Group

San Antonio, Texas, 78251, United States

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361001, China

Location

Xiamen Branch, Zhongshan hospital affilicated to Fudan University

Xiamen, Fujian, 361004, China

Location

Xiamen Fifth Hospital

Xiamen, Fujian, 361115, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471039, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hunan, 430064, China

Location

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213004, China

Location

Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215025, China

Location

The Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

Location

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Jinshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 201508, China

Location

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710063, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610032, China

Location

Zigong First People's Hospital

Zigong, Sichuan, 643000, China

Location

MeSH Terms

Interventions

Epoetin Alfa; Darbepoetin alfa; continuous erythropoietin receptor activator

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Yusha Zhu, MD, PhD

  Kind Pharmaceuticals LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: May 3, 2023
• Primary Completion: February 29, 2024
• Study Completion: April 25, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

CN (15); US (10)