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

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 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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Yusha Zhu, MD, PhD
• Email: yushazhu@kindpharmaceutical.com
• Phone: 646-725-2552

Similar studies

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

• AND017 for anemia in people on dialysis for chronic kidney disease

  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.

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• 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.

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• 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.