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Erythropoiesis-Stimulating Agent

AND017 for Anemia in Chronic Kidney Disease

Q: What number of medical facilities are currently managing this clinical trial?

<p>North America Research Institute in Riverside, <a href="https://www.withpower.com/clinical-trials/california">California</a>, Nephrology and <a href="https://www.withpower.com/clinical-trials/hypertension">Hypertension</a> Specialists in Dalton, <a href="https://www.withpower.com/clinical-trials/georgia">Georgia</a>, High Desert Nephrology Associates in Gallup, <a href="https://www.withpower.com/clinical-trials/new-mexico">New mexico</a> and seven other locations are presently accepting participants for this clinical trial.</p>

Phase 2

Waitlist Available

Research Sponsored by Kind Pharmaceuticals LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving stable HD (including combination methods such as hemodiafiltration or hemofiltration), HHD, or PD for ESKD for a minimum of 16 weeks prior to randomization and determined by the Investigator to be compliant with dialysis treatment prescription

No evidence of other causes of anemia caused by a pathologic process in the hematopoietic system, including intra- or extravascular hemolysis, or myelodysplasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 14, 15, 16, 17, 18, 19, and 20

Awards & highlights

Study Summary

This trial tests a new drug to improve anemia symptoms in kidney patients on dialysis.

Who is the study for?

This trial is for chronic kidney disease patients on dialysis with anemia. They must have been treated with certain anemia drugs for at least 6 weeks and have stable hemoglobin levels, adequate iron stores, normal liver enzymes, and a body weight between 45 to 140 kg. Excluded are those with specific eye diseases, uncontrolled hypertension, viral infections like hepatitis or HIV, planned major surgery during the study period, organ transplants or immunosuppression therapy.Check my eligibility

What is being tested?

The trial is testing AND017's safety and effectiveness in treating renal anemia in dialysis patients. It compares AND017 to existing treatments such as epoetin alfa and darbepoetin alfa (including biosimilars) and Mircera®. This phase II study will determine if AND017 can be a viable alternative treatment option.See study design

What are the potential side effects?

Potential side effects of AND017 are not detailed here but may include reactions similar to other erythropoiesis-stimulating agents (ESAs), such as high blood pressure, joint pain, muscle spasm, fever; risks associated with increased red blood cells like clotting issues could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on stable dialysis for my kidney failure for at least 16 weeks and follow my treatment plan.

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My anemia is not caused by blood or bone marrow disorders.

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I have been on an ESA treatment for at least 6 weeks with stable doses.

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My weight is between 45 and 140 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 14, 15, 16, 17, 18, 19, and 20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 14, 15, 16, 17, 18, 19, and 20

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 14, 15, 16, 17, 18, 19, and 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Mean change from baseline in Hb at Week 6

Secondary outcome measures

Change in Hb from baseline to the mean Hb levels over Week 14-20

Cumulative response rate over the entire study period

Mean Hb levels and mean change from baseline in Hb level at each visit

+3 more

Other outcome measures

EPO levels and change from baseline at each visit

Hepcidin levels and change from baseline at each visit

Iron study levels and change from baseline at each visit

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: AND017 Dose Regimen BExperimental Treatment1 Intervention

AND017 will be administrated orally at dose B once a week

Group II: AND017 Dose Regimen AExperimental Treatment1 Intervention

AND017 will be administrated orally at dose A three times a week

Group III: Erythropoietin stimulating agentActive Control1 Intervention

Investigator will select an erythropoietin stimulating agent, such as epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars, for the patient under this arm with starting doses and dose adjustment rules according to the epoetin alfa USPI or SmPC.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kind Pharmaceuticals LLCLead Sponsor

8 Previous Clinical Trials

465 Total Patients Enrolled

Yusha Zhu, MD, PhDStudy DirectorKind Pharmaceuticals LLC

3 Previous Clinical Trials

163 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have been approved to participate in this clinical trial?

"To fulfill the study requirements, 120 participants who satisfy its entry criteria must be enrolled. Patients can join from different places including North America Research Institute in Riverside, California and Nephrology and Hypertension Specialists located in Dalton, Georgia."

Answered by AI

Is this research actively recruiting participants?

"The particulars from clinicaltrials.gov reveal that this medical experiment is calling for volunteers and was first listed on May 3rd 2023, with the latest update being October 3rd of the same year."

Answered by AI

What number of medical facilities are currently managing this clinical trial?

"North America Research Institute in Riverside, California, Nephrology and Hypertension Specialists in Dalton, Georgia, High Desert Nephrology Associates in Gallup, New mexico and seven other locations are presently accepting participants for this clinical trial."

Answered by AI

Has the Food and Drug Administration approved AND017 Dose Regimen A yet?

"The AND017 Dose Regimen A is estimated to have a safety rating of 2, as it has only been tested for its security yet and lacks any clinical evidence regarding efficacy."

Answered by AI

What is the chief aim of this clinical experiment?

"The primary objective in this trial is to assess the mean change from baseline to Week 6 of Hemoglobin levels. Secondary endpoints include a comparison between the proportion of visits that maintain hemoglobin within target range (10-11 g/dL) across both fixed and titration periods, evaluation on the percentage of patients with an average hemaglobin level within 10-11g/dL at weeks 14-20, and finally, assessment on any changes in hemoglobin from baseline over the period spanning Weeks 14 - 20."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis

2023. "A Study of AND017 to Treat Anemia in Chronic Kidney Disease Patients on Dialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05265325.

All > Chronic Kidney Disease