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HemodialysisPhase 1NCT04925674

Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis.

A Phase 1 study testing HEC53856 in people with Hemodialysis and Peritoneal Dialysis, run by Sunshine Lake Pharma Co., Ltd. at 7 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 on anemia in subjects with chronic kidney disease on dialysis. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hemodialysis, Peritoneal Dialysis
What is being tested?
HEC53856
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
7 sitesChina
Study dates
10 Sep 2021to 19 Oct 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject voluntarily participated in this clinical trial and signed an informed consent form;
  • 18-70 years old, weight 45~90kg, including cut-off value;
  • Hemodialysis (Hemodialysis, HD): Patients with end-stage renal disease who are on stable dialysis receive 3 times a week hemodialysis for at least 3 months before screening, and can receive 3 times a week hemodialysis at regular intervals during the test. The duration of the subject's hemodialysis treatment must be 3-4.5 hours (including the cut-off value); Peritoneal dialysis: For patients with end-stage renal disease on stable dialysis, the subject must receive peritoneal dialysis for at least 3 months before screening;
  • Subjects stop EPO 14 days or 5 half-lives (whichever is the longest) before taking the test drug for the first time;
  • Subjects have stable dialysis methods and dialysis prescriptions, and are expected to have no major treatment changes or no drastic changes in their condition during the clinical trial period;
  • During the screening period, the hemoglobin value obtained by the two tests of Visit 1 and Visit 2 must be > or = 8.0 g/dL and <11.0 g/dL, and the difference between the two must be < or = 1.5 g/dL.

Who cannot join

  • Existence of past medical history or conditions that may cause anemia other than nephropathy, including but not limited to blood system diseases, such as thalassemia, aplastic anemia, hemolytic anemia, multiple myeloma, myelodysplastic syndrome, etc.; Autoimmune diseases that may affect red blood cell production, such as systemic lupus erythematosus, rheumatoid arthritis, etc.; Bleeding diseases, such as gastrointestinal bleeding, obstetrics and gynecology bleeding diseases, etc.
  • During the study period, those who plan to change the dialysis method/mode or the flux of the hemodialysis machine, such as changing from peritoneal dialysis to hemodialysis
  • Those who have any of the following heart/cerebrovascular diseases:
  • Acute coronary syndrome, stroke (except lacunar infarction) or thromboembolic disease (such as deep vein thrombosis or pulmonary embolism) occurred within 6 months before screening;
  • Heart Function III of New York Society of Cardiology Or grade IV congestive heart failure, or severe arrhythmia, including but not limited to ventricular tachycardia, ventricular fibrillation, III degree atrioventricular block, etc.
  • Those who have any of the following medical or surgical history:
Show all 28Show fewer
  • Those who plan to undergo major surgery 3 months before screening or during the study period (except for hemodialysis access repair) or blood transfusion therapy;
  • Have peritoneal dialysis related 3 months before screening Peritonitis, history of infection or leakage of peritoneal tube tunnel;
  • history of malignant tumor within 5 years prior to screening (except for cured skin basal cell carcinoma and cervical carcinoma in situ), or current assessment of potential malignant tumor;
  • suffering Uncontrollable or symptomatic secondary hyperparathyroidism, plasma iPTH>800pg/ml;
  • History of dysphagia or any gastrointestinal disease that affects drug absorption, history of gastric/jejunum/colon resection; f ) Those who have a serious infection and are receiving systemic antibiotic treatment;
  • Anyone who has participated or plans to participate in an organ transplant within 6 months; h) Have a history of chronic liver disease (such as: chronic infectious hepatitis, chronic autoimmune liver disease, cirrhosis Or liver fibrosis); i) Patients with a history of polycystic kidney disease.
  • Any of the following laboratory abnormalities during the screening period:
  • Folic acid <6.8nmol/L (3ng/ml) and/or VitB12<74pmol/L (100ng/ml);
  • Serum albumin <3 g/dL;
  • AIDS antibody , Treponema pallidum antibody, hepatitis B surface antigen or hepatitis C antibody positive for any one;
  • ALT>3×ULN and/or AST>3×ULN, or total bilirubin>1.5× ULN;
  • Subjects received intravenous iron supplementation within 4 weeks before screening, or used Chinese patent medicines, androgens and anabolic hormone drugs, hypoxia-inducible factor prolyl hydroxylase for the treatment of anemia within 4 weeks before screening Inhibitors (such as Roxastat capsules) and other drugs (except ESAs and their derivatives, oral irons, stable oral irons can be taken within 4 weeks before the screening, and in the screening period and after the start of the trial drug Continue to take the fixed dose for 6 weeks.)
  • Subjects who are expected to take BCRP inhibitors, BCRP inducers, CYP2C8 inhibitors and inducers within 14 days before taking the test drug (or 5 half-lives of the drug, whichever is the longest) until the end of the drug;
  • Those who have a history of drug abuse or drug abuse within 6 months before screening;
  • The mean systolic blood pressure =180 mmHg and/or the diastolic blood pressure > or = 110 mmHg of two supine blood pressure measurements at least 1 hour apart during the screening period;
  • People with a history of severe allergic disease or drug allergy, or those who are allergic to test drugs or their excipients;
  • Those who drink more than 14 units per week in the 3 months before screening (1 unit of alcohol ˜ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine), or those who cannot abstain from alcohol during the hospitalization;
  • Those who smoked more than 10 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the hospitalization;
  • Women who have a positive pregnancy test or are breastfeeding, or men and women who refuse to take effective contraceptive measures within 4 weeks from the signing of the informed consent form to the end of the last trial drug administration;
  • Participated in other clinical trials within 3 months before screening (Definition of participation: accepted experimental drugs or instrument);
  • Subjects may not be able to complete all research visits or procedures required by the research protocol, and/or fail to comply with all required research procedures;
  • The investigator believes that there are other factors that are not suitable for participating in this trial;

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Sichuan Provincial People's Hospital

    Chengdu

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou

  • The First Hospital of China Medical University

    Shenyang

  • General Hospital of Tianjin Medical University

    Tianjin

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang

  • The Fifth Affiliated Hospital Sun Yat-sen University

    Zhuhai

Other trials in China

About this study

Official title: Phase Ic Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Subjects With Renal Anemia on Dialysis

To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HEC53856 capsules on anemia in subjects with chronic kidney disease on dialysis.

Read the detailed description

The purpose of this multicenter, open-label, dose-increasing, multiple-dose study was to evaluate the safety, tolerability,PK and preliminary efficacy of HEC53856 capsules in renal anemia subjects on dialysis.

The study consists of two parts, hemodialysis or peritoneal dialysis . Within each part participants will be administrated for HEC53856.

There are three study periods:

Screening period :up to 2weeks; Treatment period: 6 weeks（except that 7 weeks in the 100mg cohort in the hemodialysis）; Follow-up period: 2weeks.

Being tested
HEC53856

What participants receive

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

  • HEC53856Drug

    The 100mg dose cohort in the hemodialysis: D1 single oral administration of the investigation product 2.5h before hemodialysis; Three times a week for 6 weeks starting from D8, oral administration of the test drug 2.5h after hemodialysis.

    The rest dose cohorts in the hemodialysis: Three times a week for 6 weeks starting from D1, oral administration of the investigation product 2.5h after hemodialysis.

    The dose cohort in the peritoneal dialysis: Three times a week for 6 weeks starting from D1, oral administration of the investigation product after fasting.

Study groups in NCT04925674
Study groupRoleWhat they receive
HEC53856ExperimentalHEC53856 Oral TIW There will be a total of 3 dose cohorts in the hemodialysis: 100mg，150mg，200mg； There will be only one dose cohort in the peritoneal dialysisp:100mg.
Receives: Drug: HEC53856

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: Up to 2 weeks after last dose

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: Up to 72 hours after single and multiple drug dosing

  2. Cmax

    Maximum observed plasma concentration

    Measured: Up to 72 hours after single and multiple drug dosing

  3. Tmax

    Time of the maximum observed plasma concentration

    Measured: Up to 72 hours after single and multiple drug dosing

  4. T½

    Apparent terminal elimination half-life

    Measured: Up to 72 hours after single and multiple drug dosing

  5. Vz/F

    Apparent volume of distribution

    Measured: Up to 72 hours after single and multiple drug dosing

  6. Changes in mean hemoglobin

    Changes in mean hemoglobin (Hb) relative to baseline during visit 8 and 9.

    Measured: Up to 2 weeks after the last dose

  7. Hemoglobin response

    Percentage of subjects who met the hemoglobin response after dosing

    Measured: Up to 2 weeks after the last dose

  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: Up to 72 hours after single and multiple drug dosing

  9. Emax

    Maximum observed EPO concentration

    Measured: Up to 72 hours after single and multiple drug dosing

  10. E-Tmax

    Time of the maximum observed EPO concentration

    Measured: Up to 72 hours after single and multiple drug dosing

  11. Serum lipid

    Changes in Serum lipid relative to baseline at visit 8.

    Measured: week 6

  12. Indicators of iron

    Changes in the Indicators of iron relative to baseline at visit 8

    Measured: week 6

  13. High-sensitivity C-reactive protein

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

    Measured: week 6

  14. Reticulocytes

    Changes in the mean Reticulocytes relative to baseline after doses.

    Measured: Up to week 8

  15. VEGF

    Changes in the VEGF relative to baseline after doses.

    Measured: week 6

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 start10 Sep 2021
  3. Primary completion19 Oct 2022
  4. Study completion19 Oct 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925674
Sponsor's protocol ID
HEC53856-RAD-103
Status last verified
Jun 2021
First submitted
30 May 2021
Last updated
15 May 2025
Results posted
No
Data monitoring committee
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 in people with Hemodialysis and Peritoneal Dialysis, run by Sunshine Lake Pharma Co., Ltd. at 7 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 6 inclusion and 28 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 7 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. 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: Up to 2 weeks after last dose). 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 NCT04925674.

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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