Chronic Renal FailurePhase 2NCT02586402
Safety & Efficacy of Pegolsihematide for Treatment of Anemia in Participants on Dialysis
A Phase 2 study testing pegol-Sihematide and Epoetin Alfa in people with Chronic Renal Failure and Anemia, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of multiple intravenous doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on dialysis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Renal Failure, Anemia, Dialysis
- What is being tested?
- pegol-Sihematide and Epoetin Alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Aug 2016
- 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
- Males or females≥18 and≤70, Weight ≥ 45 kilograms (kg)
- Participants with chronic renal failure on dialysis for ≥ 3 months prior to randomization.
- On ESAs treatment for ≥8 weeks prior to randomization with stable doses and the average doses ≤ 10000 IU/week
- Hemoglobin values of ≥ 10.0 and≤ 12.0 g/dL at Screening
- Patients with a transferrin saturation≥ 20% and a ferritin≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal.
- Signed informed consent
Who cannot join
- Pregnant or lactating females
- Red blood cell transfusion within 3 months prior to randomization
- Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products
- hemolytic syndromes or coagulation disorder
- hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, , hemoglobinopathy, pure red cell aplasia),
- Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.);
Show all 18Show fewer
- C Reactive Protein (CRP) greater than 30 mg/L within the 4 weeks prior to randomization
- Uncontrolled or symptomatic secondary hyperparathyroidism(iPTH>800pg/ml)
- Poorly controlled hypertension within 4 weeks prior to randomization
- Chronic congestive heart failure (New York Heart Association Class Ⅲ or IV)
- significant symptom within 6 months prior to randomization (e.g. myocardial infarction, serious or precarious coronary artery disease,stroke, respiratory disease, autoimmune disease, neuropathy, phrenopathy, hepatopathy including Active hepatitis B, Active hepatitis C, A positive test for HIV antibody or ALT> 2 x upper limit of normal (ULN), AST> 2 x upper limit of normal (ULN))
- tumor malignancy
- Expected survival less than 12 months
- A scheduled kidney transplant
- Major surgery (may Massive bleeding) during the study
- expected conception within 4 Weeks after the end of the Study Treatment
- The subject has participated in other clinical trial within the 12 weeks prior to randomization
- Have any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Changlin Mei, 021-81886191, Chlmei1954@126.com
About this study
Official title: A Phase 2, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Pegolsihematide for the Correction of Anemia in Patients With CRF Undergoing Dialysis and Previously Treated With ESAs
The purpose of this study is to evaluate the safety and efficacy of multiple intravenous doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on dialysis.
- Conditions
- Chronic Renal Failure, Anemia, Dialysis
- Being tested
- pegol-Sihematide, Epoetin Alfa
- Keywords
- ESAs CKD
- Medical subject headings
- Kidney Failure, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegol-SihematideDrug
Epoetin AlfaDrug
| Study group | Role | What they receive |
|---|---|---|
| Pegolsihematide | Experimental | Participants received Pegolsihematide by intravenous injection once every 4 weeks ; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). Receives: Drug: pegol-Sihematide |
| Epoetin Alfa | Active comparator | Epoetin Alfa administration 1 to 3 times per week. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. Receives: Drug: Epoetin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average reticulocytes and hemoglobin change from baseline
Measured: Baseline to Week 16
Secondary outcomes (4)
Proportion of patients whose Hb within ±1.0 g/dL of baseline during Weeks 12 to 16
Measured: week 12 to 16
Average RBC, hematokrit and reticulocytes change from baseline
Measured: Baseline to Week 16
Proportion of patients whose Hb levels were maintained within 10 to 12.0g/dL during Weeks 12 to 16
Measured: week 12 to 16
Incidence of adverse events and serious adverse events
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changli Mei, Study chair, Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586402
- Sponsor's protocol ID
- HS-EPOP2c
- Status last verified
- Oct 2015
- First submitted
- 23 Oct 2015
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Pegolsihematide for the Correction of Anemia in Patients With CRF Undergoing Dialysis and Previously Treated With ESAs
- ClinicalTrials.gov ID
- NCT02586402
- Acronym / sponsor ID
- HS-EPOP2c
- Conditions
- Chronic Renal Failure, Anemia, Dialysis
- Keywords
- ESAs CKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 26 Oct 2015 (estimated)
- 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 this study is to evaluate the safety and efficacy of multiple intravenous doses of pegol-Sihematide in participants with chronic kidney disease (CKD) who are on dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegolsihematide | Experimental | Drug: pegol-SihematideParticipants received Pegolsihematide by intravenous injection once every 4 weeks ; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). |
| Epoetin Alfa | Active comparator | Drug: Epoetin AlfaEpoetin Alfa administration 1 to 3 times per week. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females≥18 and≤70, Weight ≥ 45 kilograms (kg)
- Participants with chronic renal failure on dialysis for ≥ 3 months prior to randomization.
- On ESAs treatment for ≥8 weeks prior to randomization with stable doses and the average doses ≤ 10000 IU/week
- Hemoglobin values of ≥ 10.0 and≤ 12.0 g/dL at Screening
- Patients with a transferrin saturation≥ 20% and a ferritin≥ 100 ng/mL. vitamin B12 and folic acid level above lower limit of normal.
Key exclusion criteria (18 listed)
- Pregnant or lactating females
- Red blood cell transfusion within 3 months prior to randomization
- Known intolerance to any erythropoiesis stimulating agent (ESA) or pegylated molecule or to all parenteral iron supplementation products
- hemolytic syndromes or coagulation disorder
- hematological disease (including but not limited to myelodysplastic syndrome, hematological malignancy, , hemoglobinopathy, pure red cell aplasia),
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 |
|---|---|---|
| pegol-Sihematide | Drug | Pegolsihematide |
| Epoetin Alfa | Drug | Epoetin Alfa |
Primary outcome
Average reticulocytes and hemoglobin change from baseline
Time frame: Baseline to Week 16
4 secondary outcomes
Proportion of patients whose Hb within ±1.0 g/dL of baseline during Weeks 12 to 16
Time frame: week 12 to 16
Average RBC, hematokrit and reticulocytes change from baseline
Time frame: Baseline to Week 16
Proportion of patients whose Hb levels were maintained within 10 to 12.0g/dL during Weeks 12 to 16
Time frame: week 12 to 16
Incidence of adverse events and serious adverse events
Time frame: Baseline to Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
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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.
Changli Mei study chair
Changzheng Hospital
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 pegol-Sihematide and Epoetin Alfa in people with Chronic Renal Failure and Anemia, run by Jiangsu Hansoh 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 6 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 26 Oct 2015. 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 Changlin Mei (021-81886191, Chlmei1954@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average reticulocytes and hemoglobin change from baseline (time frame: Baseline to Week 16). 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 26 Oct 2015.