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

Primary Purpose

Renal Anemia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AND017

Placebo

About this trial

This is an interventional treatment trial for Renal Anemia

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.

13. 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.

15. Having undergone a kidney transplantation. 16. History of a seizure disorder or any occurrence of seizures in the past

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

AND017 Dose A

AND017 Dose B

AND017 Dose C

Placebo

Arm Description

AND017 will be administrated orally at dose A

AND017 will be administrated orally at dose B

AND017 will be administrated orally at dose C

Placebo will be administrated orally

Outcomes

Primary Outcome Measures

Safety Evaluations

Incidence of adverse events

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

Secondary Outcome Measures

Hb response to treatment during Period 1

Cumulative percentage of patients with Hb ≥10.0 g/dL

Percentage of responder patients

Responder is defined as a hemoglobin ≥10.0 g/dL and an increase in hemoglobin by ≥1.0 g/dL

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

Change from baseline in Hb

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

Percentage of patients who maintain hemoglobin between 10.0-11.0g/dL at each visit

Mean Hb levels at weeks 6-14 including the average of weeks 10-13

Cumulative incidence of lack of response over the entire treatment period

Hb level < 10.0 g/dL and an increase in hemoglobin from baseline of < 1 g/dL

To assess changes in the levels of PD indicator - EPO

To assess changes in the levels of EPO

To assess changes in the levels of PD indicator - hepcidin

To assess changes in the levels of hepcidin

To assess iron utilization parameter during treatment - transferrin level

To assess transferrin level during treatment

To assess iron utilization parameter during treatment - total iron-binding capacity (TIBC)

To assess TIBC level during treatment

To assess iron utilization parameter during treatment - transferrin saturation (TSAT)

To assess TSAT level during treatment

To assess iron utilization parameters during treatment - ferritin

To assess ferritin level during treatment

To assess iron utilization parameters during treatment - serum iron

To assess serum iron level during treatment

Full Information

NCT ID

NCT05035641

First Posted

April 21, 2021

Last Updated

October 2, 2023

Sponsor

Kind Pharmaceuticals LLC

1. Study Identification

Unique Protocol Identification Number

NCT05035641

Brief Title

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

Official Title

A Pilot Phase II Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Dose-Ranging, Safety and Efficacy Study of Oral AND017 to Treat Anemia in Nondialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 18, 2021 (Actual)

Primary Completion Date

July 5, 2023 (Actual)

Study Completion Date

July 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kind Pharmaceuticals LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

Detailed Description

This is a pilot phase 2, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral AND017 to treat anemia in non-dialysis-dependent chronic kidney disease patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AND017 Dose A

Arm Type

Experimental

Arm Description

AND017 will be administrated orally at dose A

Arm Title

AND017 Dose B

Arm Type

Experimental

Arm Description

AND017 will be administrated orally at dose B

Arm Title

AND017 Dose C

Arm Type

Experimental

Arm Description

AND017 will be administrated orally at dose C

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo will be administrated orally

Intervention Type

Drug

Intervention Name(s)

AND017

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Orally, 3 times per week

Primary Outcome Measure Information:

Title

Safety Evaluations

Description

Incidence of adverse events

Time Frame

Up to 17 weeks

Title

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

Description

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

Time Frame

Up to 5 weeks after dosing

Secondary Outcome Measure Information:

Title

Hb response to treatment during Period 1

Description

Cumulative percentage of patients with Hb ≥10.0 g/dL

Time Frame

Up to 5 weeks after dosing

Title

Percentage of responder patients

Description

Responder is defined as a hemoglobin ≥10.0 g/dL and an increase in hemoglobin by ≥1.0 g/dL

Time Frame

Up to 13 weeks after dosing

Title

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

Description

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

Time Frame

Up to 13 weeks after dosing

Title

Change from baseline in Hb

Description

Change from baseline in Hb

Time Frame

Up to 13 weeks after dosing

Title

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

Description

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

Time Frame

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

Title

Percentage of patients who maintain hemoglobin between 10.0-11.0g/dL at each visit

Description

Percentage of patients who maintain hemoglobin between 10.0-11.0g/dL at each visit

Time Frame

Up to 13 weeks after dosing

Title

Mean Hb levels at weeks 6-14 including the average of weeks 10-13

Description

Mean Hb levels at weeks 6-14 including the average of weeks 10-13

Time Frame

Up to 13 weeks after dosing

Title

Cumulative incidence of lack of response over the entire treatment period

Description

Hb level < 10.0 g/dL and an increase in hemoglobin from baseline of < 1 g/dL

Time Frame

Up to13 weeks after dosing

Title

To assess changes in the levels of PD indicator - EPO

Description

To assess changes in the levels of EPO

Time Frame

Baseline and at Week 2, 4, 6, 8, 10, 12, 14, and 28 days after the last dose

Title

To assess changes in the levels of PD indicator - hepcidin

Description

To assess changes in the levels of hepcidin

Time Frame

Baseline and at Week 2, 4, 6, 8, 10, 12, 14, and 28 days after the last dose

Title

To assess iron utilization parameter during treatment - transferrin level

Description

To assess transferrin level during treatment

Time Frame