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Renal AnemiaPhase 2NCT05035641

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

A Phase 2 study testing AND017 in people with Renal Anemia, run by Kind Pharmaceuticals LLC at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Renal Anemia
What is being tested?
AND017
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
8 sitesin 2 countries
Study dates
18 Oct 2021to 24 Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 15Show fewer
  • 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

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States7 sites

  • Metrolina Nephrology Associates

    Charlotte, North Carolina, 28207

  • Southeast Renal Research Institute

    Chattanooga, Tennessee, 37404

  • Elite Research Center

    Flint, Michigan, 48532

  • Amicis Research Center

    Northridge, California, 91324

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78212

  • Northwest Louisiana Nephrology

    Shreveport, Louisiana, 71101

  • Clinical Site Partners

    Winter Park, Florida, 32789

Other trials in United States

China1 site

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

Other trials in China

About this study

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

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

Read the 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.

Conditions
Renal Anemia
Being tested
AND017, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AND017Drug

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

  • PlaceboDrug

    Orally, 3 times per week

Study groups in NCT05035641
Study groupRoleWhat they receive
AND017 Dose AExperimentalAND017 will be administrated orally at dose A
Receives: Drug: AND017
AND017 Dose BExperimentalAND017 will be administrated orally at dose B
Receives: Drug: AND017
AND017 Dose CExperimentalAND017 will be administrated orally at dose C
Receives: Drug: AND017
PlaceboPlacebo comparatorPlacebo will be administrated orally
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Evaluations

    Incidence of adverse events

    Measured: Up to 17 weeks

  2. 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

    Measured: Up to 5 weeks after dosing

Secondary outcomes (15)

  1. Hb response to treatment during Period 1

    Cumulative percentage of patients with Hb ≥10.0 g/dL

    Measured: Up to 5 weeks after dosing

  2. Percentage of responder patients

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

    Measured: Up to 13 weeks after dosing

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

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

    Measured: Up to 13 weeks after dosing

  4. Change from baseline in Hb

    Change from baseline in Hb

    Measured: Up to 13 weeks after dosing

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

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

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

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

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

    Measured: Up to 13 weeks after dosing

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

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

    Measured: Up to 13 weeks after dosing

  8. 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

    Measured: Up to13 weeks after dosing

  9. To assess changes in the levels of PD indicator - EPO

    To assess changes in the levels of EPO

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

  10. To assess changes in the levels of PD indicator - hepcidin

    To assess changes in the levels of hepcidin

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

  11. To assess iron utilization parameter during treatment - transferrin level

    To assess transferrin level during treatment

    Measured: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose

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

    To assess TIBC level during treatment

    Measured: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose

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

    To assess TSAT level during treatment

    Measured: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose

  14. To assess iron utilization parameters during treatment - ferritin

    To assess ferritin level during treatment

    Measured: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose

  15. To assess iron utilization parameters during treatment - serum iron

    To assess serum iron level during treatment

    Measured: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start18 Oct 2021
  3. Primary completion5 Jul 2023
  4. Study completion24 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05035641
Sponsor's protocol ID
AND017-MN-201
Status last verified
Oct 2023
First submitted
21 Apr 2021
Last updated
4 Oct 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AND017 in people with Renal Anemia, run by Kind Pharmaceuticals LLC at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Evaluations (time frame: Up to 17 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05035641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.

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