A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia

Official title

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

Overview

This is a phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in anemic patients with End-Stage-Kidney-Disease (ESKD)

Interventions

• Drug AND017 capsules
  AND017 capsules administered orally with a starting dose of 10 mg TIW
• Drug ESA
  ESA injection and dose based on package insert and local practice

Primary outcome measures

• Evaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD [Time frame: From Week 23 to Week 27]

Secondary outcome measures (12)

• The percentage of responders [Time frame: From baseline to Week 27]
• Percentage of participants that maintained Hb level over target lower limit [Time frame: From Week 5 to Week 27]
• Maintenance of Hb within 10.0-12.0 g/dL after initial achievement ≥10.0 g/dL during the entire study treatment period. [Time frame: From baseline to Week 53]
• Incidence of extreme Hb levels of ≥13.0 g/dL or <7.5 g/dL during the entire study treatment period [Time frame: From baseline to Week 53]
• Incidence of excessive erythropoiesis [Time frame: From baseline to Week 53]
• The cumulative incidence of Hb non-response [Time frame: From baseline to Week 27]
• Mean Hb change from baseline averaged over Weeks 5-27 [Time frame: From baseline to Week 27]
• Mean Hb change from baseline averaged over Weeks 23-27 [Time frame: From baseline to Week 27]
• Mean Hb change from baseline averaged over Weeks 13-17 [Time frame: From baseline to Week 17]
• Mean Hb change from baseline averaged over Weeks 27-53 [Time frame: From baseline to Week 53]
• Mean Hb change from baseline averaged over Weeks 49-53 [Time frame: Mean Hb change from baseline averaged over Weeks 49-53]
• During the entire treatment period, mean Hb at each visit [Time frame: From baseline to Week 53]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Fudan Univeristy Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT07494409 · AND017-CN-302 · CTR20253615

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)
• NMPA/CDE CTR20253615 (chinadrugtrials.org.cn platform)

View this study on ClinicalTrials.gov ↗