AND017 for anemia in people on dialysis for chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fudan Univeristy Zhongshan Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yusha Zhu, MD, PhD
• Email: yushazhu@kindpharmaceutical.com
• Phone: 6467252552

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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

  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.

  Recruiting Phase 3 Kind Pharmaceuticals LLC · Beijing, Beijing Municipality · NCT07487727

• Enarodustat for Anemia in Non-Dialysis CKD Patients

  This study tests whether enarodustat can help increase hemoglobin safely in adults with CKD who aren’t on dialysis, grouping participants by inflammation level.

  Recruiting Huashan Hospital · Shanghai, Shanghai Municipality · NCT07741279

• Treatment of anemia in patients with chronic kidney disease on dialysis

  This study is testing if a new anemia treatment called efepoetin alfa works better than darbepoetin alfa for people with chronic kidney disease who are on dialysis.

  Recruiting at 42 sites Phase 3 Genexine, Inc. · Yerevan and 57 other locations · NCT06466785

• Evaluating the safety of Desidustat for treating anemia in chronic kidney disease patients

  This study is testing the long-term safety of a medication called Desidustat for treating anemia in people with chronic kidney disease.

  Recruiting Phase 4 Zydus Lifesciences Limited · Sheikhpura, Bihar · NCT05515367

• Switching dialysis patients on HIF-PHI to long‑acting pegmolesatide for renal anemia

  This study will test whether switching dialysis patients with renal anemia who are taking HIF‑PHI medication to long‑acting pegmolesatide keeps hemoglobin stable and is safe.

  Recruiting Guangdong Provincial People's Hospital · Beijing, Beijing Municipality and 23 other locations · NCT07136792

• Switching to pegmolesatide for anemia in people on dialysis

  This 24-week test will try whether switching dialysis patients whose anemia isn't at goal from rHuEPO to pegmolesatide alone or combined with roxadustat keeps or raises hemoglobin better than continuing rHuEPO.

  Recruiting Phase 4 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07045155

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.