AND017 for anemia in people with chronic kidney disease who are not on dialysis.

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

This Phase 3 study will test whether AND017 raises hemoglobin and is safe in adults with anemia from non-dialysis-dependent chronic kidney disease, compared with standard ESA treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kind Pharmaceuticals LLC (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07487727 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label, active-controlled Phase 3 trial comparing AND017 to approved erythropoiesis-stimulating agents (ESAs) in adults with anemia due to non-dialysis-dependent CKD. Participants are enrolled either as ESA/HIF-PHI–naïve or as stable ESA-treated patients and are randomized to receive AND017 or an ESA. The trial tracks hemoglobin response and safety/tolerability throughout the treatment period. The study is being conducted at Peking University People's Hospital in Beijing.

Who should consider this trial

Good fit: Adults with CKD stage 3–5 who are not on dialysis, meet the trial hemoglobin criteria, and are either ESA/HIF-PHI–naïve or stably treated with an approved ESA are the intended participants.

Not a fit: Patients who are on dialysis, have an imminent need to start dialysis, or who do not meet the trial hemoglobin or prior-treatment timing criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, AND017 could provide an effective alternative to current ESAs to raise hemoglobin and reduce anemia-related symptoms in non-dialysis CKD patients.

How similar studies have performed: Other drugs in the HIF-PHI class and standard ESAs have previously shown the ability to raise hemoglobin in non-dialysis CKD populations, so the approach has supporting clinical precedent.

Eligibility criteria

Key Inclusion Criteria:

* A diagnosis of CKD confirmed at screening, KDOQI CKD stage 3, 4, or 5 defined by estimated Glomerular Filtration Rate (eGFR) using the CKD Epidemiology Collaboration (EPI) formula.
* Not on dialysis and no clinical evidence of impending need to initiate dialysis during the study treatment.
* Prior ESA and hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment

  1. ESA/HIF-PHI-naïve: Defined as no use of any ESA/HIF-PHI treatment for at least 12 weeks before randomization; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be ≥7.5 g/dL and \<10.0 g/dL with a difference of ≤1.3 g/dL between the two values;
  2. ESA-treated: Defined as having received an approved ESA, administered intravenously or subcutaneously, for at least 6 weeks prior to randomization, with no change in ESA product and no treatment interruption exceeding 2 consecutive weeks; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be 9.0-12.0 g/dL inclusive.
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3× upper limit of normal (ULN)
* Transferrin saturation (TSAT) ≥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/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

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yusha Zhu, MD, PhD

Conditions Anemia Due to Chronic Kidney Disease; anemia; CKD