AND017 for Kidney Anemia

No longer recruiting at 7 trial locations

Overseen By Yusha Zhu

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kind Pharmaceuticals LLC

Must not be taking: HIF-PHI, ESAs, Anabolic steroids, others

Disqualifiers: Retinal lesions, Autoimmune anemia, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AND017 to manage anemia in individuals with chronic kidney disease who are not on dialysis. The goal is to assess the safety and effectiveness of AND017 compared to a placebo. Participants will receive either varying doses of AND017 or a placebo to evaluate their effectiveness. This trial may suit individuals with chronic kidney disease who have specific blood and iron levels and are not experiencing other serious health issues, such as recent major surgeries or significant heart problems. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have taken certain treatments like hypoxia-inducible factor prolyl hydroxylase inhibitors or erythropoiesis stimulating agents within 5 weeks before starting the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AND017 is generally safe for people. In an earlier study, patients with chronic kidney disease (not on dialysis) and anemia tolerated AND017 well, with most experiencing no serious side effects. The treatment also increased hemoglobin levels, the protein in red blood cells that carries oxygen. Higher doses of AND017 led to greater improvements in anemia without compromising safety.

Another study found that patients with end-stage kidney disease on regular dialysis also tolerated AND017 well. These results are encouraging for those considering participation in trials for AND017. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for NDD-CKD?

Unlike the standard of care for anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD) patients, which typically involves erythropoiesis-stimulating agents (ESAs) and iron supplements, AND017 offers a fresh approach. Researchers are excited about AND017 because it acts directly on the body's natural pathways to boost red blood cell production, potentially minimizing the need for additional iron. This oral medication could simplify treatment regimens, making it easier for patients to manage their condition without the frequent injections required by ESAs. Plus, the different dosing options (A, B, and C) allow for personalized treatment plans, which might enhance effectiveness and reduce side effects.

What evidence suggests that this trial's treatments could be effective for NDD-CKD?

Research has shown that AND017 may help treat anemia in patients with chronic kidney disease who are not on dialysis. Early results suggest that AND017 is safe and effective, as studies have found it helps raise hemoglobin levels, which are crucial for carrying oxygen in the blood. Although some side effects have been noted, the treatment is generally well-tolerated. The drug boosts the production of red blood cells, directly addressing anemia. These encouraging findings suggest that AND017 could be a convenient and effective way to manage anemia in this patient group. Participants in this trial will receive different doses of AND017 or a placebo to further evaluate its effectiveness and safety. ^{1 3 6 7 8}

Who Is on the Research Team?

Yusha Zhu, MD PhD

Principal Investigator

Kind Pharmaceuticals LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

TSAT ≥ 20% or ferritin ≥ 100 ng/mL at screening test

AST and ALT ≤ 3×ULN

You have chronic kidney disease, not receiving dialysis, with an eGFR <60 mL/min/1.

Exclusion Criteria

Anemia that is possibly mainly caused by concurrent autoimmune disease with inflammatory symptoms

Total bilirubin >1.5xULN, or AST>3xULN, or ALT>3xULN, or ALP>3xULN, or previous or concurrent serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.) thought to be caused by ESAs.

Patients that have major surgery planned during the study period.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral AND017 or placebo to treat anemia in NDD-CKD patients

13 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AND017
• Placebo

How Is the Trial Designed?

Group I: AND017 Dose C Experimental Treatment 1 Intervention

AND017 will be administrated orally at dose C

Group II: AND017 Dose B Experimental Treatment 1 Intervention

AND017 will be administrated orally at dose B

Group III: AND017 Dose A Experimental Treatment 1 Intervention

AND017 will be administrated orally at dose A

Group IV: Placebo Placebo Group 1 Intervention

Placebo will be administrated orally

Who Is Running the Clinical Trial?

Kind Pharmaceuticals LLC

Lead Sponsor

Trials

9

Recruited

640+

Citations

1. journals.lww.com journals.lww.com/jasn/fulltext/2024/10001/efficacy_and_safety_of_and017_for_treatment_of.1503.aspx

Efficacy and Safety of AND017 for Treatment of Anemia in... Treatment-emergent adverse events (TEAEs) occurred in 81.4% of patients in the AND017 10 mg TIW group, 75.4% in the AND017 16 mg QW group, and 66.1% in the ESA ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05035641?term=AND-017&rank=6

A Study of AND017 to Treat Anemia in Non-dialysis- ... This is a pilot phase 2, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral AND017 ...

3. biospace.com biospace.com/press-releases/kind-presents-positive-results-of-and017-to-treat-anemia-associated-with-chronic-kidney-disease-in-two-phase-ii-and-two-phase-i

KIND Presents Positive Results of AND017 to Treat ... For the safety assessment, treatment emergent adverse events (TEAEs) occurred in 91 patients (78.4%) treated with AND017 and 39 patients (66.1%) ...

4. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/4140/533091/Pharmacological-Evaluation-of-a-First-in-Class

Pharmacological Evaluation of a First-in-Class Hemoglobin ... These results indicate that AND017 has the potential to be a safe, efficacious and convenient treatment for MDS patients in the future.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124052418

Pharmacological Evaluation of a First-in-Class Hemoglobin ... AND017 also reduced the WBC, MCV and MCH and increased platelets in Townes SCD mouse model. These results indicate that AND017 has the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06302491

A Study of Safety and Efficiency of AND017 in Patients ... This is a phase II, randomized, double-blinded, placebo-controlled study to treat patients with transfusion-dependent and non-transfusion dependent β ...

7. thalassaemia.org.cy thalassaemia.org.cy/news/sickle-cell-disease-fda-grants-orphan-drug-designation-to-and017/

FDA Grants Orphan Drug Designation to AND017 – TIF AND017 is an innovative hemoglobin-elevating agent designed to target multiple stages of the red blood cell (RBC) life cycle. It is currently ...

8. journals.lww.com journals.lww.com/jasn/fulltext/2024/10001/safety_and_efficacy_of_and017,_a_hypoxia_inducible.1221.aspx

Safety and Efficacy of AND017, a Hypoxia-Inducible... AND017 was safe and well tolerated in patients with NDD-CKD and anemia. AND017 effectively increased Hb level in a dose-dependent manner starting at 8 mg TIW.