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Chronic Kidney DiseasesPhase 1NCT04925661

HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia

A Phase 1 study testing HEC53856 and Roxadustat in people with Chronic Kidney Diseases and Renal Anemia, run by Sunshine Lake Pharma Co., Ltd. at 8 sites in China.

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

To evaluate the safety, tolerability , pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Kidney Diseases, Renal Anemia
What is being tested?
HEC53856 and Roxadustat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
8 sitesChina
Study dates
4 Nov 2021to 29 Aug 2023
Phase
Phase 1
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who agree to participate in this clinical trial and sign an informed consent form;
  • Age 18~65 years old; Weight 40~90Kg, including critical value;
  • Glomerular filtration rate (eGFR) calculated by CKD-EPI formula 15mL/min/1.73 m^2 < or = eGFR < 60 mL/min/1.73 m^2 diagnosed chronic kidney disease patients who have not received dialysis;
  • The hemoglobin values obtained during the last two screening periods at least 6 days apart must be > or = 8.0 g/dL and <10 g/dL.

Who cannot join

  • Existence of diseases or conditions other than nephropathy that may cause anemia, including but not limited to 1) blood system diseases, such as thalassemia, aplastic anemia, hemolytic anemia, multiple myeloma, myelodysplastic syndrome, etc.; 2) may affect red blood cells The resulting autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, etc.; 3) Bleeding diseases, such as gastrointestinal bleeding, obstetrics and gynecology bleeding diseases, etc.; 4) Elective surgery expected during the study period;
  • Drugs used to treat anemia within 8 weeks before the first administration, including but not limited to erythropoiesis stimulators (ESAs) and their derivatives, hypoxia inducible factor prolyl hydroxylase inhibitors (HIF-PHI), androgens And anabolic hormone drugs, intravenous iron, Chinese patent medicine, Chinese herbal medicine, etc. (Can accept patients who have used a fixed dose of oral iron within 4 weeks before screening, and continue to take it during the screening period and the first 4 weeks after starting to take the test drug The fixed dose remains unchanged.);
  • Those who have received blood transfusion within 3 months before the first administration;
  • Folic acid <6.8nmol/L (3ng/ml) and (or) VitB12<74pmol/L (100ng/ml) during the screening period;
  • Clinically significant chronic liver and gallbladder disease, or obvious abnormal liver function: ALT>3×ULN and/or AST>3×ULN, or total bilirubin>1.5×ULN;
  • Serum albumin <3 g/dL;
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  • The mean systolic blood pressure > or = 160 mmHg and/or the diastolic blood pressure > or = 100 mmHg of the two blood pressure measurements at least one hour apart during the screening period;
  • Suffering from uncontrollable or symptomatic secondary hyperparathyroidism, plasma iPTH > 500pg/ml;
  • A history of acute or chronic pancreatitis, or acute or chronic pancreatitis at the time of screening, or blood amylase > or = 3×ULN;
  • History of malignant tumors within 5 years (except for cured skin basal cell carcinoma and cervical carcinoma in situ), or current assessment of potential malignant tumors;
  • Patients with acute coronary syndrome, stroke ( except for lacunar infarction )or thromboembolic diseases (such as deep vein thrombosis or pulmonary embolism) occurred in the 6 months before screening;
  • New York Society of Cardiology, grade III or IV congestive heart failure, or severe arrhythmia, including but not limited to atrial fibrillation, III degree atrioventricular block, etc.;
  • AIDS antibody, Treponema pallidum antibody, hepatitis B surface antigen or hepatitis C antibody positive for any of them;
  • People with a history of severe allergic disease or drug allergy, or those who are allergic to experimental drugs or their excipients;
  • Patients with clinically severe infections who are receiving systemic antibiotic treatment;
  • Those who have started dialysis or plan to start dialysis treatment within 6 months;
  • Anyone who has participated in or plans to participate in organ transplantation within 6 months;
  • Patients with hemoglobinosis, polycystic kidney disease, or no kidney;
  • Women during pregnancy or lactation, or fertile men and women who refuse to take effective contraceptive measures voluntarily from the beginning of screening to 4 weeks after the administration of the last trial drug;
  • Participated in other clinical trials within 3 months before screening (Definition of participation: accepted trial drug or instrument);
  • The investigator believes that there are other factors that are not suitable for participating in this trial.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • The sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou

  • Zhejiang Provincal People's Hospital

    Hangzhou

  • The People's Hospital of Guangxi Zhuang Autonmous Region

    Nanning

  • Huashan Hospital

    Shanghai

  • Ruijin Hospital

    Shanghai

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The First Affiliated Hospital of Xiamen University

    Xiamen

Other trials in China

About this study

Official title: Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia

To evaluate the safety, tolerability , pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia.

Read the detailed description

This is a MultiCenter, Randomized, Blinded, Active Drug and Placebo-controlled, Dose-escalated Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia. Each part participants will be randomly administrated for HEC53856 or placebo or roxadustat.

The study consisted of three study periods as follows:

Screening period: up to 2 weeks； Treatment period: 8 weeks； Post-Treatment Follow-Up period: 4 weeks.

Being tested
HEC53856, Roxadustat, Placebo
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

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

  • HEC53856Drug

    Either dose of HEC53856 will be administered after fasting .

  • RoxadustatDrug

    Roxadustat will be administered after fasting .

  • PlaceboDrug

    Either dose of placebo will be administered after fasting .

Study groups in NCT04925661
Study groupRoleWhat they receive
HEC53856ExperimentalDrug: HEC53856 TIW dosing, capsule There will be a total of 3 dose cohorts: 100mg, 150mg, 200 mg
Receives: Drug: HEC53856
RoxadustatActive comparatorDrug: roxadustat TIW dosing There will be only one cohort: 70mg
Receives: Drug: Roxadustat
PlaceboPlacebo comparatorDrug: placebo TIW dosing, capsule There will be a total of 3 dose cohorts: 100mg, 150mg, 200 mg
Receives: Drug: Placebo

What is being measured

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

  1. Incidence of Adverse Events

    To assess the safety and tolerability of therapy by incidence of treatment-emergent adverse events after multiple doses of HEC53856 capsule

    Measured: Through study completion, an average of 12 weeks.

Secondary outcomes (15)

  1. AUC0-t

    Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration

    Measured: Day 1(Dosing) until Day 55 after single and multiple drug dosing.

  2. Cmax

    Maximum observed plasma concentration

    Measured: Day 1(Dosing) until Day 55 after single and multiple drug dosing.

  3. Tmax

    Time of the maximum observed plasma concentration

    Measured: Day 1(Dosing) until Day 55 after single and multiple drug dosing.

  4. T½

    Apparent terminal elimination half-life

    Measured: Day 1(Dosing) until Day 55 after single and multiple drug dosing.

  5. Vz/F

    Apparent volume of distribution

    Measured: Day 1(Dosing) until Day 55 after single and multiple drug dosing.

  6. Changes in mean hemoglobin

    Changes in mean hemoglobin (Hb) relative to baseline during weeks 8 and 10.

    Measured: week 10

  7. Hemoglobin response

    Percentage of subjects who met the hemoglobin response after dosing

    Measured: week 10

  8. E-AUC0-t

    Area under the EPO concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration

    Measured: Day 1(Dosing) until Day 55 after single and multiple drug dosing.

  9. Emax

    Maximum observed EPO concentration

    Measured: Day 1(Dosing) until Day 55 after single and multiple drug dosing.

  10. E-Tmax

    Time of the maximum observed EPO concentration

    Measured: Day 1(Dosing) until Day 55 after single and multiple drug dosing.

  11. Serum lipid

    Changes in Serum lipid relative to baseline at weeks 8.

    Measured: Up to Day 55

  12. Indicators of iron

    Changes in the Indicators of iron relative to baseline at weeks 8.

    Measured: Up to Day 55

  13. High-sensitivity C-reactive protein

    Changes in the High-sensitivity C-reactive protein relative to baseline at weeks 8.

    Measured: Up to Day 55

  14. Reticulocytes

    Changes in the mean Reticulocytes relative to baseline after doses.

    Measured: Up to Day 85

  15. VEGF

    Changes in the VEGF relative to baseline after doses.

    Measured: Up to Day 55

Timeline

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

  1. First posted14 Jun 2021
  2. Study start4 Nov 2021
  3. Primary completion29 Aug 2023
  4. Study completion29 Aug 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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925661
Sponsor's protocol ID
HEC53856-RAD-102
Status last verified
Apr 2023
First submitted
30 May 2021
Last updated
15 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HEC53856 and Roxadustat in people with Chronic Kidney Diseases and Renal Anemia, run by Sunshine Lake Pharma Co., Ltd. at 8 sites in China.

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 4 inclusion and 21 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 15 May 2025. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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: Through study completion, an average of 12 weeks.). 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 NCT04925661.

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 15 May 2025.

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