A Study of AND017 to Treat Anemia in Non-dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients

NCT05035641 | Completed Phase 2 FDA Drug

• 1 other identifier: AND017-MN-201
• Study Type: interventional
• Target: 113
• Locations: 2 countries
• Sites: 8

Brief Summary

This is a pilot phase II study to evaluate the safety and efficacy of AND017 in NDD-CKD patients

Conditions

Renal Anemia

Outcome Measures

Primary Outcomes (2)

• Safety Evaluations

  Incidence of adverse events

  Up to 17 weeks

• Rate of rise in hemoglobin for each of 3 dose levels as compared with placebo from baseline to 5 weeks after TIW oral dosing

  Calculate the slope of a linear regression for each patient using all hemoglobin data collected during the Fixed-Dose Period

  Up to 5 weeks after dosing

Secondary Outcomes (15)

• Hb response to treatment during Period 1

  Up to 5 weeks after dosing

• Percentage of responder patients

  Up to 13 weeks after dosing

• Percentage of visits at which patients maintain hemoglobin between 10.0-11.0 g/dL after achieving hemoglobin ≥10.0 g/dL

  Up to 13 weeks after dosing

• Change from baseline in Hb

  Up to 13 weeks after dosing

• Change in hemoglobin levels from baseline to the mean of weeks 10-13

  Baseline and at Week 10, 11, 12, 13, and 14

Study Arms (4)

AND017 Dose A

EXPERIMENTAL

AND017 will be administrated orally at dose A

Drug: AND017

AND017 Dose B

EXPERIMENTAL

AND017 will be administrated orally at dose B

Drug: AND017

AND017 Dose C

EXPERIMENTAL

AND017 will be administrated orally at dose C

Drug: AND017

Placebo

PLACEBO COMPARATOR

Placebo will be administrated orally

Drug: Placebo

Interventions

AND017 DRUG

Orally, 3 times per week in Period 1 and randomize to TIW or QW group at the same dose in Period 2

AND017 Dose A; AND017 Dose B; AND017 Dose C

Placebo DRUG

Orally, 3 times per week

Placebo

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic kidney disease, not receiving dialysis, with an eGFR \<60 mL/min/1.73 m2.
• Baseline Hb level ≥ 7.5 g/dL and \<10.0 g/dL.
• TSAT ≥ 20% or ferritin ≥ 100 ng/mL at screening test
• Serum folate and vitamin B12 ≥ lower limit of normal at screening test
• AST and ALT ≤ 3×ULN.
• Total bilirubin ≤ 1.5×ULN.

You may not qualify if:

• Concurrent retinal neovascular lesions requiring treatment including proliferative diabetic retinopathy, exudative age-related macular degeneration, retinal vein occlusion, macular edema, etc.
• Anemia that is possibly mainly caused by concurrent autoimmune disease with inflammatory symptoms
• History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent symptomatic gastroparesis despite being on treatment.
• Clinically significant bleeding (eg, requiring transfusion or drop in Hb of ≥ 2g/dL) within 4 weeks of first dose; no bleeding diathesis or risk of bleeding that has not been medically or surgically corrected at least 4 weeks prior to first dose of study drug.
• Uncontrolled hypertension defined as patients with hypertension having more than one of three diastolic blood pressure values \>95 mmHg and each test at least 5 min apart during the screening assessment.
• Concurrent congestive heart failure (New York Heart Association \[NYHA\] Class III or higher).
• History of stroke, transient ischemic attack, myocardial infarction, thromboembolic event, pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.
• Concurrent anemia due to another cause other than renal anemia
• Known hemosiderosis, hemochromatosis or hyper-coagulable condition
• Any treatment with a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) within 5 weeks before randomization.
• Having received treatment with erythropoiesis stimulating agents, androgenic anabolic steroids, testosterone enanthate, or mepitiostane within 5 weeks before the first dose.
• 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 with a history of significant liver disease or active liver disease. Investigators should discuss this with the Medical Monitor for cases where there is doubt about whether to exclude or not.
• \. Patients that have major surgery planned during the study period. 14. Having undergone blood transfusion and/or a surgical procedure within 8 weeks before the screening assessment.
• \. Having undergone a kidney transplantation. 16. History of a seizure disorder or any occurrence of seizures in the past

Sponsors & Collaborators

• Kind Pharmaceuticals LLC: lead

Study Sites (8)

Amicis Research Center

Northridge, California, 91324, United States

Location

Clinical Site Partners

Winter Park, Florida, 32789, United States

Location

Northwest Louisiana Nephrology

Shreveport, Louisiana, 71101, United States

Location

Elite Research Center

Flint, Michigan, 48532, United States

Location

Metrolina Nephrology Associates

Charlotte, North Carolina, 28207, United States

Location

Southeast Renal Research Institute

Chattanooga, Tennessee, 37404, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212, United States

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Study Officials

• Yusha Zhu, MD PhD

  Kind Pharmaceuticals LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: September 5, 2021
• Study Start: October 18, 2021
• Primary Completion: July 5, 2023
• Study Completion: July 24, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CN (1)