AzTrials
AzTrials

Renal Anemia of Chronic Kidney DiseasePhase 2NCT04885647

A Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease

A Phase 2 study testing YPEG-rhEPO in people with Renal Anemia of Chronic Kidney Disease, run by Xiamen Amoytop Biotech Co., Ltd. at 17 sites in China.

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

The purpose of this study is to evaluate the effectiveness and safety of YPEG rhEPO, a recombinant human erythropoietin pegylated by Y shape polyethylene glycol, in patients with anemia due to Chronic Kidney Disease (CKD), assessed by hemoglobin maintenance, adverse events and health-related quality of life. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Anemia of Chronic Kidney Disease
What is being tested?
YPEG-rhEPO
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
17 sitesChina
Study dates
12 Mar 2021to 5 Jan 2022
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 18 and 70 years old, including 18 and 70 years.
  • Subjects who are diagnosed of chronic kidney disease and receiving hemodialysis (KT/V greater than or equal to 1.2). And those who had received hemodialysis, performed 2 to 3 times a week and 4 to 5 hours for every dialysis, for at least 12 weeks prior to deliver of YPEG-EPO.
  • Subjects receiving rhEPO treatment, including subcutaneous and intravenous injection, for anemia due to chronic kidney disease for at least 12 weeks before randomized. And in addition, the serum hemoglobin should keep stable during the previous 12 weeks, which was defined as serum hemoglobin obtained from tests taken once a month (once a month means at least 4 weeks interval between two tests) were always kept between 100g/L and 120g/L, or else mean hemoglobin of two different tests, which were taken at least 4 weeks apart, is between 100g/L and 120g/L.
  • Transferrin saturation (TSAT) greater than 20% or serum ferritin (SF) greater than 200ng/mL, serum folate greater or equal to the lower normal limit (ULN), serum vitamin B12 greater or equal to ULN，before enrollment.
  • Understand and sign the informed consent form voluntarily.

Who cannot join

  • Women of pregnancy, lactating, or planning to pregnant, or patients who are planning to donate sperms/eggs during the study period.
  • Subjects who are allergic to rhEPO or any of its components, or with any other evidenced allergy history that make it not suitable for participation.
  • Subjects who are receiving Roxadustat Capsules at screening.
  • Anemia caused by diseases or causes other than CKD, such as bleeding, hemolysis, vitamin or folate deficiency. Obvious bleeding evidence that requires blood transfusion during the lead-in period.
  • Subjects suffering from pure red-cell anemia (PRCA) according to previously erythropoietin treatment.
  • Subjects with serious disease or function deficiency in major organ/system, such as：
Show all 19Show fewer
  • Medical history of myocardial infarction, cerebral stroke, vascular access thrombosis, or pulmonary embolism. Combined congestive heart failure (NYHA cardiac function equal to or grade than III). Hypertensions poorly controlled by medication (systolic blood pressure higher than 170mmHg and/or diastolic blood pressure higher than 100mmHg), or postural hypotension (systolic blood pressure below 90mmHg).
  • Medical history of malignancy, hematological disease, obvious bleeding disease, epilepsy, neuropsychiatric disease, or family history of neuropsychiatric disease.
  • Poorly controlled autoimmune diseases (including but not limit to systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, autoimmune thrombocytopenia).
  • Poorly controlled endocrine diseases, (including but not limit to thyroid disease, parathyroid disease, diabetes mellitus).
  • Co-infected with HAV, HBV, HCV, HIV, Syphilis, etc..
  • Currently suffering from severe infection or inflammation (C-reactive protein greater than 30mg / L), or currently receiving antibiotics.
  • Red blood cell count greater than 6.0×10^12/L for men while greater than 5.5×10^12/L for female; Platelets greater than 500×10^9/L; serum albumin lower than 30g/L; Alanine aminotransferase higher than 2 ULN, aspartame aminotransferase higher than 2ULN; Parathyroid hormone greater than 800pg/mL.
  • Subjects who plan to undergo coronary artery bypass grafting (CABG), to undergo orthopedic surgery, to receive kidney transplantation, or to undergo any other major operation during the study period.
  • Drug addicts or alcoholics.
  • Vascular malformations (such as internal jugular vein malformation) makes it inappropriately for Hemodialysis catheterization.
  • Expected survival of a certain subject is less than 12 months.
  • Subjects participated in any other clinical trial within 3 months prior to screening.
  • Any other situation that is not suitable for participation in this study according to the investigator's judgment.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • Beijing Anzhen Hospital,Capital Medical University

    Beijing, Beijing Municipality

  • The Third Xiangya Hospital Of Central South University

    Changsha, Hunan

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • The First Affiliated Hospital Of Chengdu Medical college

    Chengdu, Sichuan, 361028

  • The Second Affiliated Hospital Of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning

  • The First Affiliated Hospital Of Guangzhou Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • The Third Affiliated Hospital of Sun Yat sen University

    Guanzhou, Guangdong

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • The First Affiliated Hospital Of Baotou Medical college,Inner Mongolia University Of Science and Technology

    Hohhot, Inner Mongol

  • Huai'an Second People's Hospital/The Affiliated Huaian Hospital Of Xuzhou Medical University

    Huai'an, Jiangsu

  • Lishui Municipal Central Hospital

    Lishui, Zhejiang

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality

  • Renmin Hospital of Wuhan University/Hubei General Hospital

    Wuhan, Hubei

  • Xi'an Gaoxin Hospital

    Xi’an, Shanxi

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-label, Phase 2 Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease, Who Has Previously Treated With rhEPO and Maintains the Hemoglobin in a Stabilize State

The purpose of this study is to evaluate the effectiveness and safety of YPEG rhEPO, a recombinant human erythropoietin pegylated by Y shape polyethylene glycol, in patients with anemia due to Chronic Kidney Disease (CKD), assessed by hemoglobin maintenance, adverse events and health-related quality of life.

Being tested
YPEG-rhEPO
Keywords
YPEG rhEPO, rhEPO, erythropoietin, anemia, dialysis, hemodialysis, chronic kidney disease
Medical subject headings
Anemia, Renal Insufficiency, Chronic

What participants receive

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

  • YPEG-rhEPODrug

    YPEG-rhEPO，low dose，were subcutaneous injected once every two weeks for 13 weeks.

  • YPEG-rhEPODrug

    YPEG-rhEPO，low dose，were subcutaneous injected once every four weeks for 13 weeks.

  • YPEG-rhEPODrug

    YPEG-rhEPO, high dose，were subcutaneous injected once every two weeks for 13 weeks.

  • YPEG-rhEPODrug

    YPEG-rhEPO，high dose，were subcutaneous injected once every four weeks for 13 weeks.

Study groups in NCT04885647
Study groupRoleWhat they receive
Arm1ExperimentalLow dose once every 2 weeks group
Receives: Drug: YPEG-rhEPO
Arm2ExperimentalLow dose once every 4 weeks group
Receives: Drug: YPEG-rhEPO
Arm3ExperimentalHigh dose once every 2 weeks group
Receives: Drug: YPEG-rhEPO
Arm4ExperimentalHigh dose once every 4 weeks group
Receives: Drug: YPEG-rhEPO

What is being measured

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

  1. Changes of mean hemoglobin compared to baseline.

    Measured: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

Secondary outcomes (7)

  1. Proportion of patients with hemoglobin keeping within the target range (the target hemoglobin range is defined as hemoglobin keeping between 100g/L and 120g/L).

    Measured: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

  2. Proportion of patients with hemoglobin fluctuations within ±10g/L compared to baseline.

    Measured: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

  3. Mean time of hemoglobin keeping within the target range.

    Measured: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

  4. Mean time from baseline to the first dose adjustment.

    Measured: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

  5. Changes of hemoglobin compared to baseline at the time of first dose adjustment.

    Measured: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

  6. Proportion of patients with dose adjustment.

    Measured: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

  7. Proportion of patients requiring blood transfusion.

    Measured: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.

Timeline

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

  1. First posted13 May 2021
  2. Study start12 Mar 2021
  3. Primary completion5 Jan 2022
  4. Study completion5 Jan 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04885647
Sponsor's protocol ID
TB1901EPO
Status last verified
Dec 2022
First submitted
8 May 2021
Last updated
16 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing YPEG-rhEPO in people with Renal Anemia of Chronic Kidney Disease, run by Xiamen Amoytop Biotech Co., Ltd. at 17 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 5 inclusion and 19 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 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 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?

Changes of mean hemoglobin compared to baseline. (time frame: 14 weeks for every two weeks groups, and 16 weeks for every four weeks groups.). 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 NCT04885647.

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 16 Dec 2022.

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