AzTrials
AzTrials

Renal AnemiaPhase 2NCT05265325

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

A Phase 2 study testing AND017 capsules TIW, AND017 capsules QW and epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars in people with Renal Anemia, run by Kind Pharmaceuticals LLC at 25 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a phase II study to evaluate the safety and efficacy of AND017 in renal anemia patients on dialysis Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Anemia
What is being tested?
AND017 capsules TIW, AND017 capsules QW and epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
25 sitesin 2 countries
Study dates
3 May 2023to 25 Apr 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body weight from 45 to 140 kg inclusive
  • 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.
  • Patient must have been on IV or SC of an approved ESA under the prescription for at least 6 weeks, and ≤25% change in dose between the two most recent doses, prior to randomization.
  • The mean of two hemoglobin values during screening (at least 7 days apart) must be 9.0-11.0 g/dL with a difference of ≤1.3 g/dL between the two values
  • TSAT ≥ 20% or ferritin ≥ 100 ng/mL at screening
  • Folate ≥ 3.0 ng/mL and vitamin B12 ≥ lower limit of normal (LLN) at screening
  • AST and ALT < 3×ULN at screening.
  • No evidence of other causes of anemia caused by a pathologic process in the hematopoietic system, including intra- or extravascular hemolysis, or myelodysplasia.

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 determined by the Investigator to be caused by concurrent autoimmune disease with inflammatory symptoms (such as systemic erythematosus, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, Sjögren's syndrome, celiac disease, etc.).
  • History of gastric/intestinal resection considered influential on the absorption of drugs in the gastrointestinal tract (excluding resection of gastric or colon polyps) or concurrent symptomatic gastroparesis despite on treatment.
  • Clinically significant bleeding (eg, requiring transfusion or drop in Hb of ≥ 2 g/dL) within 4 weeks of first dose; 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 24Show fewer
  • History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment.
  • Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody at the screening assessment, or positive for human immunodeficiency virus in a past test.
  • Not complying with COVID-19 prevention and control requirements per local policy.
  • Concurrent primary form of anemia other than renal anemia (hemolytic anemia, thalassemia, sickle cell anemia, history of pure red cell aplasia, history of myelodysplastic syndrome or multiple myeloma, iron deficiency, etc.). Any question of the primary cause of anemia should be discussed with the Medical Monitor before the patient signs informed consent.
  • Known hemosiderosis, hemochromatosis or hyper-coagulable condition
  • Known to be hypersensitive or intolerant to ESA.
  • Having received treatment with androgenic anabolic steroids, testosterone enanthate, or mepitiostane within 5 weeks prior to the first dose.
  • Any treatment with a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) within 5 weeks prior to the first dose.
  • TBIL>1.5 ULN, or AST>3 ULN, or ALT>3 ULN, or ALP>3 ULN, or previous or concurrent serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.) thought to be caused by any other HIF-PHI.
  • Previous or current malignant tumor (patients with no recurrence for at least 5 years are eligible. Exemption: basal cell and squamous cell carcinoma not under active stage).
  • Patients with a history of significant liver disease or active liver disease.
  • Patients that have major surgery planned during the study period.
  • Patients that have undergone blood transfusion or with evidence of major blood loss within 8 weeks before the screening assessment. Investigators should discuss this with the Medical Monitor for cases where there is doubt about whether to exclude or not.
  • Patients unable to discontinue IV iron during the screening period.
  • Patients with an organ transplant on immunosuppression, or with a scheduled kidney or any other organ transplant within the duration of the study, or without kidney.
  • Serum albumin < 2.5 g/dL at screening.
  • Patients with other chronic medical condition that may limit life expectancy in the opinion of the Investigator.
  • History of a seizure disorder or any occurrence of seizures in the past.

Trial locations and contacts

25 sites in 2 countries.

25 sites in 2 countries

China15 sites

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213004

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610032

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

  • The Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, 116001

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471039

  • Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Zhongshan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200031

  • Jinshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 201508

  • Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215025

  • Renmin Hospital of Wuhan University

    Wuhan, Hunan, 430064

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710063

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361001

  • Xiamen Branch, Zhongshan hospital affilicated to Fudan University

    Xiamen, Fujian, 361004

  • Xiamen Fifth Hospital

    Xiamen, Fujian, 361115

  • Zigong First People's Hospital

    Zigong, Sichuan, 643000

Other trials in China

United States10 sites

  • Nephrology Associates of Western New York

    Cheektowaga, New York, 14225

  • Nephrology and Hypertension Specialists

    Dalton, Georgia, 30720

  • High Desert Nephrology Associates

    Gallup, New Mexico, 87301

  • Rocky Mountain Kidney Care

    Lone Tree, Colorado, 80124

  • US Renal Care - Pine Bluff

    Pine Bluff, Arkansas, 71603

  • North America Research Institute

    Riverside, California, 92503

  • South Texas Renal Care Group - San Saba

    San Antonio, Texas, 78207

  • Clinical Advancement Center PLLC

    San Antonio, Texas, 78212

  • South Texas Renal Care Group

    San Antonio, Texas, 78251

  • Nephrology Consultants of Northwest Ohio - Toledo

    Toledo, Ohio, 43613

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Open-label, Randomized, Active-Controlled Study of Efficacy and Safety of AND017 in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

This is a phase II study to evaluate the safety and efficacy of AND017 in renal anemia patients on dialysis

Read the detailed description

This is a Phase II study to assess the safety and efficacy of AND017 in patients with CKD who are anemic and on dialysis.

Conditions
Renal Anemia
Being tested
AND017 capsules TIW, AND017 capsules QW, epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars

What participants receive

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

  • AND017 capsules TIWDrug

    Orally, 3 times per week in Period 1 and dose adjustment in Period 2 at 2 mg/4 mg and 2-weeks interval according to Hb levels

  • AND017 capsules QWDrug

    Orally, once per week in Period 1 and dose adjustment in Period 2 at 4 mg/8 mg and 2-weeks interval according to Hb levels

  • epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilarsDrug

    Dose regimen and adjustment rules according to the USPI or SmPC or local practice

Study groups in NCT05265325
Study groupRoleWhat they receive
AND017 Dose Regimen AExperimentalAND017 will be administrated orally at dose A three times a week
Receives: Drug: AND017 capsules TIW
AND017 Dose Regimen BExperimentalAND017 will be administrated orally at dose B once a week
Receives: Drug: AND017 capsules QW
Erythropoietin stimulating agentActive comparatorInvestigator 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.
Receives: Drug: epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars

What is being measured

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

  1. Incidence of adverse events

    Incidence of adverse events

    Measured: Up to 20 weeks

  2. Mean change from baseline in Hb at Week 6

    Mean change from baseline in Hb at Week 6

    Measured: Up to 5 weeks after dosing

Secondary outcomes (6)

  1. Proportion of responders, during the entire study period.

    Responders are defined as patients whose Hb achieved ≥ 10.0 g/dL and an increase ≥ 1.0 g/dL from baseline

    Measured: up to Week 20

  2. Mean proportion of visits at which patients maintain Hb within the target range from baseline during the fixed-dose period and titration period

    Target range is defined as 10.0-11.0 g/dL inclusive and an increase ≥ 1.0 g/dL.

    Measured: up to Week 20

  3. Proportion of patients with a mean Hb between 10.0-11.0 g/dL inclusive during Week 14-20

    Proportion of patients with a mean Hb between 10.0-11.0 g/dL inclusive during Week 14-20

    Measured: at Week 14, 15, 16, 17, 18, 19, and 20

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

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

    Measured: Baseline and at Week 14, 15, 16, 17, 18, 19, and 20

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

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

    Measured: up to Week 20

  6. Cumulative response rate over the entire study period

    Response is defined as Hb < 10.0 g/dL or an increase in hemoglobin of <1 g/dL from baseline

    Measured: up to Week 20

Timeline

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

  1. First posted3 Mar 2022
  2. Study start3 May 2023
  3. Primary completion29 Feb 2024
  4. Study completion25 Apr 2024

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
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05265325
Sponsor's protocol ID
AND017-MN-202
Status last verified
Jun 2024
First submitted
22 Feb 2022
Last updated
28 Jun 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AND017 capsules TIW, AND017 capsules QW and epoetin alfa, darbepoetin alfa, Mircera®, or their biosimilars in people with Renal Anemia, run by Kind Pharmaceuticals LLC at 25 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 8 inclusion and 24 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 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China, United States. 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. 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?

Incidence of adverse events (time frame: Up to 20 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 NCT05265325.

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 28 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in