AND017 for anemia in people on dialysis for chronic kidney disease

A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia

This trial will test whether AND017 capsules can increase hemoglobin and be safe in adults on dialysis for end-stage kidney disease who have anemia, compared with standard ESA treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kind Pharmaceuticals LLC (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07494409 on ClinicalTrials.gov

What this trial studies

This is a phase 3, randomized, open-label, active-controlled trial comparing oral AND017 capsules to standard erythropoiesis-stimulating agents (ESA) in dialysis-dependent CKD patients with anemia. Eligible participants must have been on stable hemodialysis or peritoneal dialysis for at least 16 weeks and receiving IV or SC ESA for at least 6 weeks, with screening hemoglobin between 9.0 and 12.0 g/dL and adequate iron, folate, and B12 status. The study will monitor hemoglobin responses and safety outcomes, including adverse events and liver function, while following a predefined dosing and monitoring schedule. The sponsor is Kind Pharmaceuticals LLC and the listed study site is Fudan University Zhongshan Hospital in Shanghai.

Who should consider this trial

Good fit: Adults on stable hemodialysis or peritoneal dialysis for at least 16 weeks who have been on IV or SC ESA therapy for at least 6 weeks and have a screening hemoglobin of 9.0–12.0 g/dL with acceptable iron, folate, and B12 levels are ideal candidates.

Not a fit: Patients with active inflammatory or autoimmune disease that affects erythropoiesis, concurrent retinal neovascular lesions requiring treatment, significant liver enzyme elevations, or hemoglobin outside the 9.0–12.0 g/dL range are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, AND017 could provide an effective alternative to injectable ESAs for raising hemoglobin in dialysis patients with CKD-related anemia.

How similar studies have performed: Other oral hypoxia-inducible factor prolyl hydroxylase inhibitors and similar agents have raised hemoglobin in CKD patients, including those on dialysis, so the approach has precedent though safety and regulatory findings have varied across programs.

Eligibility criteria

Key Inclusion Criteria:

* Receiving stable hemodialysis (including combination methods such as hemodiafiltration or hemofiltration), peritoneal dialysis 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
* The mean of two hemoglobin values during screening must be 9.0-12.0 g/dL.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\<3× upper limit of normal (ULN)
* Transferrin saturation ≥20% or ferritin ≥100 ng/mL at screening test
* Serum folate and vitamin B12 ≥ lower limit of normal (LLN) at screening test

Key Exclusion Criteria:

* Concurrent retinal neovascular lesions requiring treatment
* Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis or concurrent autoimmune disease with inflammatory symptoms
* History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract or concurrent symptomatic gastroparesis despite being on treatment
* Uncontrolled hypertension, defined as patients with hypertension having more than one of three systolic blood pressure \>180 mmHg, or diastolic blood pressure \>110 mmHg 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
* Participants with a history of significant liver disease or active liver disease
* History of a seizure disorder or any occurrence of seizures in the past
* Serum albumin (ALB) \< 2.5 g/dL at screening test
* Prior ESA/hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment caused total bilirubin \>1.5xULN, or AST/ALT/ ALP\>3xULN, or serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.)
* Any prior functioning organ transplant or a scheduled organ transplantation, or anephric

Where this trial is running

Shanghai

• Fudan Univeristy Zhongshan Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Yusha Zhu, MD, PhD

Conditions Anemia Due to Chronic Kidney Disease; anemia; CKD; ESKD