Renal AnemiaPhase 2NCT05629598
A Study of PEG-EPO Injection (CHO Cells) for Maintenance Therapy of Patients With Renal Anemia .
A Phase 2 study testing Recombinant human erythropoietin injection and Human erythropoietin injection in people with Renal Anemia, run by Angde Biotech Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of the study is to explore the optimal dose and administration of the experimental drug, and to evaluate the safety and efficacy of the drug in patients with renal anemia. Patients with renal anemia on regular dialysis treatment are expected to be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Anemia
- What is being tested?
- Recombinant human erythropoietin injection and Human erythropoietin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2022to 16 Aug 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients at the age of 18~75 (including critical value).
- Patients clinically diagnosed with renal anemia who have received dialysis for at least 12 weeks (hemodialysis≥3 times/week, total urea clearance index (Kt/V) ≥1.2 or urea reduction rate (URR) ≥65%; peritoneal dialysis≥4 times/day, weekly Kt/V≥1.7);
- Hb in screening period should be within the range of 100~130g/L (including both ends), and the deviation should not exceed 10g/L;
- Iron status (TSAT ≥20% or SF ferritin ≥100μg/L) during screening.
- Have been stably treated with short-acting EPO 1-3 times per week for at least 12 weeks before baseline;
- Consent to use reliable contraceptive methods and no family planning from the screening period to 3 months after the last administration；
- Voluntarily participate in the trial and sign the informed consent form.
Who cannot join
- Patients with a history of severe allergies (including drug allergies), especially allergic to erythropoietin, or to any component of the test drug (e.g. polyethylene glycol);
- Have a history of kidney transplantation or plan to undergo kidney transplantation during the trial；
- Have any other disease that causes chronic anemia (e.g., sickle cell anemia, myelodysplastic syndrome, hematologic malignancy, myeloma, hemolytic anemia, pure red cell aplastic anemia) or PRCA following therapy of erythropoietin protein;
- Suffered from acute or chronic blood loss (such as gastrointestinal bleeding) or undergwent surgical procedures due to massive bleeding within 3 months before screening, or plan to have a surgery during the clinical trial (except for arteriovenous fistula or peritoneal dialysis tube adjustment);
- Have a history of malignant tumors within the past 5 years (excluding non-melanoma skin cancer or excised carcinoma in situ);
- Suffer from autoimmune diseases (such as rheumatoid arthritis or systemic lupus erythematosus) or diseases of endocrine system (such as poorly controlled diabetes mellitus complicated with peripheral vascular diseases, severe secondary hyperparathyroidism [parathyroid hormone > 800ng/L]);
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- Received systemic antibiotic treatment or C-reactive protein ≥30mg/L within 4 weeks due to severe infection before screening;
- The following conditions occur during screening period:
- Hepatic dysfunction (AST or ALT>3 times ULN); Coagulation dysfunction (activated partial thrombin time > 1.5 times ULN); Folic acid or vitamin B12 deficiency (serum folic acid level <LLN, vitamin B12 <LLN); Positive for HBsAg, HBcAb, HIV-ABb, HCV-AbB or TP-Ab;
- Suffer from severe thromboembolic disease, poorly controlled severe hypertension (SBP before dialysis > 170mmHg or DBP ≥100mmHg) or hypotension (SBP before dialysis <90mmHg);
- Suffer from severe cardiovascular and cerebrovascular disease, severe or unstable coronary artery disease, heart failure (NYHA CLASS III or IV), or those who received coronary artery bypass grafting or percutaneous coronary intervention within 6 months, or those who had a history of myocardial infarction or stroke within 3 months;
- Received androgen therapy or blood transfusion within 8 weeks before screening period;
- Received long-acting ESAs within 3 months or HIF-PHI (e.g., rosalat) within 2 weeks before initial administration;
- Participated in other clinical trials as a subject within 4 weeks before screening period or the duration from the last administration to enrollment was shorter than the 5 half-lives of the drug;
- Have a history of epileptic seizures or mental illness;
- Alcoholism, drug abuse or drug addiction
- Pregnant or breastfeeding;
- Investigator considers not suitable to enter this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospitial,College of Medicine,Zhejiang University
Hanzhou, Zhejiang, 310003
Jianghua Chen, Master, 0571-87236996, zyct79@163.com
Xiaoying Du, Master, 0571-87236996, zyct79@163.com
About this study
Official title: A Phase Ⅱ Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Polyethylene Glycol Recombinant Human Erythropoietin Injection (CHO Cell) in Optimal Dose and Administration Regimen for Maintenance Therapy in Patients With Regular Dialysis Renal Anemia.
The purpose of the study is to explore the optimal dose and administration of the experimental drug, and to evaluate the safety and efficacy of the drug in patients with renal anemia. Patients with renal anemia on regular dialysis treatment are expected to be enrolled in this study.
Read the detailed description
This study is a multi-center, randomized, open-label, positive controlled phase II clinical study. A total of 125 to 150 patients with renal anemia receiving regular dialysis were enrolled in this study. Those patients were randomly allocated to 5 treatment groups in a ratio of 1:1:1:1:1, with 25 to 30 patients in each group.
- Conditions
- Renal Anemia
- Being tested
- Recombinant human erythropoietin injection, Human erythropoietin injection
- Keywords
- PEG-EPO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human erythropoietin injectionBiological
The dose of PEG-EPO (CHO cells) is converted according to the average weekly dose of short-acting EPO before randomization (4 weeks before randomization) multiplied by the corresponding conversion coefficient (low conversion coefficient is 0.004, High conversion coefficient is 0.008).
Human erythropoietin injectionBiological
Refer to the product instructions
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Recombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)* 0.004 (conversion coefficient), Q2W for administration. Receives: Biological: Recombinant human erythropoietin injection |
| B1 | Experimental | Recombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)* 0.008 (conversion coefficient), Q2W for administration. Receives: Biological: Recombinant human erythropoietin injection |
| A2 | Experimental | Recombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)* 0.004 (conversion coefficient), Q4W for administration. Receives: Biological: Recombinant human erythropoietin injection |
| B2 | Experimental | Recombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)* 0.008 (conversion coefficient), Q4W for administration. Receives: Biological: Recombinant human erythropoietin injection |
| C | Active comparator | Human erythropoietin injection；Refer to the product instructions. Receives: Biological: Human erythropoietin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mean hemoglobin compared to baseline during fixed treatment
Change of mean hemoglobin (Hb) content from baseline during fixed treatment (fixed treatment：week 1 to week 6)
Measured: Day1-Day42
Change of mean hemoglobin during dose adjustment period
Change of mean hemoglobin compared to baseline from week 13 to 18 during dose adjustment period (dose adjustment period: week 7 to week 18/week 20).
Measured: Day85-Day126
Secondary outcomes (14)
Proportion of patients with hemoglobin keeping within the target range
Proportion of patients with hemoglobin keeping within the target range (target range: the variation from baseline Hb is within ±10g/L, and HB is in the range of 100-130g/L) during treatment period (fixed treatment, week 13 to 18 during dose adjustment period).
Measured: Day1-Day42、Day85-Day126
Reticulocyte count, Hematocrit, Erythrocyte count
Changes of mean values of other evaluation indexes (including HCT, RET, RBC) between baseline and different stages of treatment (fixed treatment period, week 13 to 18 of dose adjustment period).
Measured: Day1-Day42、Day85-Day126
Proportion of patients receiving red blood cell transfusion and number of transfusions during the trial.
Measured: Day1-Day126/140
Number of iron deficiency, number of patients and proportion of patients with iron deficiency during the trial
Iron deficiency was defined as SF≤100μg/L and TSAT≤20% in peritoneal dialysis subjects; SF≤200μg/L and TSAT≤20% in hemodialysis subjects.
Measured: Day1-Day126/140
The number and proportion of patients with dose adjustments during the trial
Measured: Day1-Day126/140
Anti-drug antibody
The incidence of ADA and Nab
Measured: 1,5, 9, 13, 17 weeks (before administration) and 28±2 days after the last administration (A2/B2group ,A1/B1 patients with intensive blood collection) or 14±2 days after the last administration (A1/B1 patients with sparse blood collection)
Adverse events
Any adverse event that occurred during the clinical trials of all patients.
Measured: Day1-Day126/140
Cmax
Maximum observed plasma concentration of EPO.
Measured: Day1-Day126/140
Tmax
Time to maximum observed plasma concentration of EPO.
Measured: Day1-Day126/140
AUC 0-t
Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration of EPO.
Measured: Day1-Day126/140
AUC 0-∞
Area under the plasma concentration-time curve from time 0 to infinity.
Measured: Day1-Day126/140
Emax
Maximal effect concentriation
Measured: Day1-Day126/140
Tmax of Emax
Time to maximal effect concentriation
Measured: Day1-Day126/140
AUE0-t
Area under the plasma effect-concentriation curve from time 0 to the time of the last measurable concentration of EPO.
Measured: Day1-Day126/140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start13 Apr 2022
- Primary completion17 Mar 2023 (estimated)
- Study completion16 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angde Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629598
- Sponsor's protocol ID
- CRAD-006-02
- Status last verified
- Nov 2022
- First submitted
- 27 Jun 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Clinical Study on the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Polyethylene Glycol Recombinant Human Erythropoietin Injection (CHO Cell) in Optimal Dose and Administration Regimen for Maintenance Therapy in Patients With Regular Dialysis Renal Anemia.
- ClinicalTrials.gov ID
- NCT05629598
- Acronym / sponsor ID
- CRAD-006-02
- Conditions
- Renal Anemia
- Keywords
- PEG-EPO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Angde Biotech Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 17 Mar 2023 (estimated)
- Study completion
- 16 Aug 2023 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to explore the optimal dose and administration of the experimental drug, and to evaluate the safety and efficacy of the drug in patients with renal anemia. Patients with renal anemia on regular dialysis treatment are expected to be enrolled in this study.
Detailed description
This study is a multi-center, randomized, open-label, positive controlled phase II clinical study. A total of 125 to 150 patients with renal anemia receiving regular dialysis were enrolled in this study. Those patients were randomly allocated to 5 treatment groups in a ratio of 1:1:1:1:1, with 25 to 30 patients in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Biological: Recombinant human erythropoietin injectionRecombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)* 0.004 (conversion coefficient), Q2W for administration. |
| B1 | Experimental | Biological: Recombinant human erythropoietin injectionRecombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)* 0.008 (conversion coefficient), Q2W for administration. |
| A2 | Experimental | Biological: Recombinant human erythropoietin injectionRecombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)* 0.004 (conversion coefficient), Q4W for administration. |
| B2 | Experimental | Biological: Recombinant human erythropoietin injectionRecombinant human erythropoietin injection; Weekly dose of short-acting EPO (IU/kg)* 0.008 (conversion coefficient), Q4W for administration. |
| C | Active comparator | Biological: Human erythropoietin injectionHuman erythropoietin injection；Refer to the product instructions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients at the age of 18~75 (including critical value).
- Patients clinically diagnosed with renal anemia who have received dialysis for at least 12 weeks (hemodialysis≥3 times/week, total urea clearance index (Kt/V) ≥1.2 or urea reduction rate (URR) ≥65%; peritoneal dialysis≥4 times/day, weekly Kt/V≥1.7);
- Hb in screening period should be within the range of 100~130g/L (including both ends), and the deviation should not exceed 10g/L;
- Iron status (TSAT ≥20% or SF ferritin ≥100μg/L) during screening.
- Have been stably treated with short-acting EPO 1-3 times per week for at least 12 weeks before baseline;
Key exclusion criteria (18 listed)
- Patients with a history of severe allergies (including drug allergies), especially allergic to erythropoietin, or to any component of the test drug (e.g. polyethylene glycol);
- Have a history of kidney transplantation or plan to undergo kidney transplantation during the trial；
- Have any other disease that causes chronic anemia (e.g., sickle cell anemia, myelodysplastic syndrome, hematologic malignancy, myeloma, hemolytic anemia, pure red cell aplastic anemia) or PRCA following therapy of erythropoietin protein;
- Suffered from acute or chronic blood loss (such as gastrointestinal bleeding) or undergwent surgical procedures due to massive bleeding within 3 months before screening, or plan to have a surgery during the clinical trial (except for arteriovenous fistula or peritoneal dialysis tube adjustment);
- Have a history of malignant tumors within the past 5 years (excluding non-melanoma skin cancer or excised carcinoma in situ);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human erythropoietin injectionThe dose of PEG-EPO (CHO cells) is converted according to the average weekly dose of short-acting EPO before randomization (4 weeks before randomization) multiplied by the corresponding conversion coefficient (low conversion coefficient is 0.004, High conversion coefficient is 0.008). | Biological | A1, A2, B1, B2 |
| Human erythropoietin injectionRefer to the product instructions | Biological | C |
Primary outcome
Change of mean hemoglobin compared to baseline during fixed treatment
Time frame: Day1-Day42
Change of mean hemoglobin (Hb) content from baseline during fixed treatment (fixed treatment：week 1 to week 6)
Change of mean hemoglobin during dose adjustment period
Time frame: Day85-Day126
Change of mean hemoglobin compared to baseline from week 13 to 18 during dose adjustment period (dose adjustment period: week 7 to week 18/week 20).
14 secondary outcomes
Proportion of patients with hemoglobin keeping within the target range
Time frame: Day1-Day42、Day85-Day126
Reticulocyte count, Hematocrit, Erythrocyte count
Time frame: Day1-Day42、Day85-Day126
Proportion of patients receiving red blood cell transfusion and number of transfusions during the trial.
Time frame: Day1-Day126/140
Number of iron deficiency, number of patients and proportion of patients with iron deficiency during the trial
Time frame: Day1-Day126/140
The number and proportion of patients with dose adjustments during the trial
Time frame: Day1-Day126/140
Anti-drug antibody
Time frame: 1,5, 9, 13, 17 weeks (before administration) and 28±2 days after the last administration (A2/B2group ,A1/B1 patients with intensive blood collection) or 14±2 days after the last administration (A1/B1 patients with sparse blood collection)
Adverse events
Time frame: Day1-Day126/140
Cmax
Time frame: Day1-Day126/140
Tmax
Time frame: Day1-Day126/140
AUC 0-t
Time frame: Day1-Day126/140
AUC 0-∞
Time frame: Day1-Day126/140
Emax
Time frame: Day1-Day126/140
Tmax of Emax
Time frame: Day1-Day126/140
AUE0-t
Time frame: Day1-Day126/140
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human erythropoietin injection and Human erythropoietin injection in people with Renal Anemia, run by Angde Biotech Pharmaceutical Co., Ltd. at 1 site 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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianghua Chen, Master (0571-87236996, zyct79@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mean hemoglobin compared to baseline during fixed treatment (time frame: Day1-Day42). 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?
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 29 Nov 2022.