Patient of Anemia in Chronic Renal Failure With HemodialysisPhase 2NCT04231292
A Phase 2 Clinical Study of Pegerythropoietin Injection (RD01) for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis
A Phase 2 study testing RD01 and Recombinant Human Erythropoiesis Injection (CHO cell) in people with Patient of Anemia in Chronic Renal Failure With Hemodialysis, run by Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd at 1 site in China.
Trial summary
A multicenter randomized, single blind, active comparator controlled phase 2 study which is to evaluate the effectiveness, safety and the PK/PD characteristics of different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance therapy in the treatment of anemia in chronic renal failure… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patient of Anemia in Chronic Renal Failure With Hemodialysis
- What is being tested?
- RD01 and Recombinant Human Erythropoiesis Injection (CHO cell)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 31 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic renal failure who are undergoing maintenance hemodialysis for at least 12 weeks;
- 18 ≤ age ≤ 75 years of age, male or female;
- Patients who have received short-acting EPO treatment and meets the treatment standard (hemoglobin 100 ~ 120 g / L). The mean Hb value in the screening period (at least two weeks apart ) is within the range of 100 ~ 120 g / L (both ends). The difference is less than 10g / L;
- Evaluation of iron status during the screening period, transferrin saturation (TSAT) ≥20% or serum ferritin (SF) ≥200 μg / L;
- Evaluation of dialysis adequacy during the screening period, with SpKt / V≥1.2 or URR≥65%;
- Subjects agree to use reliable contraceptives from the screening period to within 6 months after the last medication
- Sign the informed consent.
Who cannot join
- Patients who have received or plan to have a kidney transplant during the study period
- Except of renal anemia, there are other diseases that cause chronic anemia (such as sickle cell anemia, myelodysplastic syndrome, hematological malignancies, myeloma, hemolytic anemia, pure red blood cell aplastic anemia)
- Patients with acute or chronic blood loss (such as upper gastrointestinal bleeding) in the past 3 months or patients who have undergone surgery with extensive bleeding, or patients who plan to undergo surgery during the study period
- Patients with coagulation dysfunction (time to activate partial thromboplastin> 1.5 times the upper limit of normal value)
- The following circumstances (including but not limited to) during the screening, investigators evaluated that it is not suitable for enrollment:
- Abnormal liver function (aspartate aminotransferase or alanine aminotransferase is more than 3 times the upper limit of normal value);
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- Patients who were positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antigen (HBeAg), HIV antibody (HIV-Ab), hepatitis C virus antibody (HCV-Ab) or Treponema pallidum antibody;
- Patients with severe secondary hyperparathyroidism (iPTH> 1000 ng / L);
- Patients with severe hypertension and poor control of blood pressure (systolic blood pressure> 180 mmHg or diastolic blood pressure> 100 mmHg)
- Patients with severe thromboembolic disease
- People with severe cardio-cerebral vascular disease (excluding luminal infarction), severe or unstable coronary artery disease, heart failure (NYHA III or IV) or myocardial infarction or stroke within 3 months
- Patients with malignant tumors (excluding non-melanoma skin cancer or resected cancer in situ)
- People with a history of severe allergies (including drug allergies), allergies to erythropoietin, or allergic to any component of the test drug (such as human serum albumin)
- People with severe infection who are receiving systemic antibiotics
- Patients who have received androgen therapy or blood transfusion therapy within the last 8 weeks;
- Participated in other new drug clinical trials as a subject within 3 months or the withdrawal time was shorter than the 5 half-life of the test drug at the time of enrollment (whichever is the longest);
- Patients with a history of seizures
- Pregnant and lactating women
- Alcohol, drug or drug addicts
- Other situations that the researcher believes may affect validity judgment or are not suitable for participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renal Rheumatology and Immunology department Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
Official title: A Multicenter, Randomized, Single-blind, Active Comparator Controlled Phase 2 Clinical Study on the Effectiveness, Safety and Pharmacokinetics of Pegerythropoietin Injection (RD01) in Different Medication Schemes for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis
A multicenter randomized, single blind, active comparator controlled phase 2 study which is to evaluate the effectiveness, safety and the PK/PD characteristics of different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance therapy in the treatment of anemia in chronic renal failure patients with hemodialysis
Read the detailed description
This trial is a multicenter randomized, single blind, active comparator controlled phase 2 study. The study is divided into two stages. The first stage lasts for 18 weeks, and is divided into fixed dose period (day 1~ 6th week ) and dose adjustment period (7th ~ 18th week). The second stage lasts for 28 weeks, and is also divided into dose adjustment period (19th ~ 38th week) and evaluation period (39th ~ 46th week).
Patients are randomly assigned to seven study groups in the first stage. Of all these seven groups, six groups are: Group A (0.8μg/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)、Group B (1.2μg/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)、Group C (1.6μg/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)、 Group D (0.8ug/kg RD01, once every two weeks, intravenous injection, for 18 weeks)、Group E ( 150 IU/kg rHuEPO, once a week, subcutaneous injection, for 18 weeks )、Group F (8μl /kg placebo, once every two weeks, for 6 weeks; then 150 IU/kg rHuEPO, once a week, subcutaneous injection, 7th ~ 18th week ).
At the beginning of the second stage, some patients in these six goups need to be be randomized again. Of which patients in Group A、B、C are randomly assigned to Group a ( RD01, once every two weeks, subcutaneous injection, 19th ~ 46th week )、Group b (RD01, once every four weeks, subcutaneous injection, 19th ~ 46th week)、Group c (RD01, once every six weeks, subcutaneous injection, 19th ~ 46th week); Patients in Group D enter directly to Group d (RD01, once every four weeks, intravenous injection, 19th ~ 46th week); Patients in Group E and F are randomly assigned to Group e (rHuEPO once a week, intravenous injection, 19th ~ 46th week ) and Group f (rHuEPO once a week, subcutaneous injection, 19th ~ 46th week). The starting dose of the second stage for individual patient in all groups refers to the weekly dose at the end of the first stage .
During the whole study period, all patients in six groups are not allowed to adjust dosage in the first 6 weeks, while in the remaining trial period dosage adjustment was allowed once every two weeks if necessary.
There is a special Group G (1.6μg/kg RD01, once every four weeks, subcutaneous injection, Day 1 ~ 28th week), all patients are allowed to adjust dosage during the whole 28 weeks.
This phase 2 study is to evaluate the effectiveness, safety and the PK/PD characteristics of different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance therapy in the treatment of anemia in chronic renal failure patients with hemodialysis
- Being tested
- RD01, Recombinant Human Erythropoiesis Injection (CHO cell), placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD01Drug
Also called pegerythropoietin Injection
RD01 is a PEGylated recombinant human erythropoietin with the same biological effects as natural erythropoietin
Recombinant Human Erythropoiesis Injection (CHO cell)Drug
Also called rHuEPO
rHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A +Group a | Experimental | Group A: 0.8μg/kg RD01, once every two weeks, Day 1~ 18th week;Group a: refers to the weekly dose at the end of the first stage , once every two weeks, 19th~46th week Receives: Drug: RD01 |
| Experimental Group B +Group b | Experimental | Group B: 1.2μg/kg RD01, once every two weeks, Day 1~ 18th week; Group b: refers to the weekly dose at the end of the first stage , once every four weeks, 19th~46th week Receives: Drug: RD01 |
| Experimental Group C +Group c | Experimental | Group C: 1.6μg/kg RD01, once every two weeks, Day 1~ 18th week; Group c: refers to the weekly dose at the end of the first stage , once every six weeks, 19th~46th week Receives: Drug: RD01 |
| Experimental Group D +Group d | Experimental | Group D: 0.8μg/kg RD01, once every two weeks, Day 1~ 18th week; Group d: refers to the weekly dose at the end of the first stage , once every four weeks, 19th~46th week Receives: Drug: RD01 |
| Experimental Group E +Group e | Active comparator | Group E: 150IU/kg rHuEPO, once a weeks, subcutaneous administration, Day 1~ 18th week; Group e: refers to the weekly dose at the end of the first stage , once a weeks, intravenous administration, 19th~46th week Receives: Drug: Recombinant Human Erythropoiesis Injection (CHO cell) |
| Experimental Group F +Group f | Placebo comparator | Group F: 8μl placebo, once every two weeks, for 6 weeks; 150 IU/kg rHuEPO, once week, subcutaneous injection, 7th ~ 18th week; Group f: refers to the weekly dose at the end of the first stage , once a weeks, subcutaneous administration, 19th~46th week Receives: Drug: Recombinant Human Erythropoiesis Injection (CHO cell); Drug: placebo |
| Experimental Group G | Experimental | Group G: 1.6μg/kg RD01, once every four weeks, Day 1~ 28th week; Receives: Drug: RD01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy index : The change of hemoglobin concentration of experimental group from baseline to the end of 4th and 6th week
Measured: Day 1~4th week & Day 1~6th week
Primary efficacy index: The difference of hemoglobin concentration between the experimental group and the placebo group at the end of 4th and 6th week;
Measured: Day 1~4th week & Day 1~6th week
Primary efficacy index: hemoglobin concentration change from baseline to the end of first stage
The amount of change in hemoglobin concentration from baseline to the end of the first stage
Measured: Day 1~18th week
Primary efficacy index: hemoglobin concentration change from baseline to the evaluation periods in the second stage (39th ~46th week)
The amount of change in hemoglobin concentration from baseline to the evaluation periods in the second stage (39th ~46th week).
Measured: Day 1~ evaluation periods (39th ~46th week)
Secondary outcomes (9)
Secondary efficacy index: the optimal dosage
The optimal dosage of the subjects at the end of the first stage and the evaluation period (39th ~46th week) in the second stage
Measured: the end of 18th week & 39th ~46th week
Secondary efficacy index: maintenance rate
the proportion of subjects whose average Hb concentration remain within the target range during the evaluation period
Measured: 39th-46th week
Secondary efficacy index : Proportion of subjects with unstable Hb during the evaluation period
Measured: 39th-46th week
Secondary efficacy index: proportion of times of Hb remains within the target range
the proportion of times the measured Hb concentration remains within the target range during the evaluation period;
Measured: 39th-46th week
Secondary efficacy index: EPO dose conversion coefficient of RD01
EPO dose conversion factor for subjects at the end of the first stage and evaluation periods in the second stage
Measured: end of 18th week & 39th ~46th week
Safety indicator: adverse events
the type, proportion and severity of adverse events
Measured: for 46 weeks
Immunogenicity indicator: incidence of anti-RD01 antibodies
incidence of anti-RD01 antibodies
Measured: for 46 weeks
Maximum Plasma Concentration (Cmax)
the Cmax of RD01 in patients with long-term medication.
Measured: for 46 weeks
Area Under the Curve (AUC)
the AUC of RD01 in patients with long-term medication.
Measured: for 46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Mar 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient of Anemia in Chronic Renal Failure With HemodialysisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengzhen Sciprogen Bio-pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231292
- Sponsor's protocol ID
- SZSBE-RD01-HD-II-01
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blind, Active Comparator Controlled Phase 2 Clinical Study on the Effectiveness, Safety and Pharmacokinetics of Pegerythropoietin Injection (RD01) in Different Medication Schemes for the Treatment of Anemia in Chronic Renal Failure Patients With Hemodialysis
- ClinicalTrials.gov ID
- NCT04231292
- Acronym / sponsor ID
- SZSBE-RD01-HD-II-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Shengzhen Sciprogen Bio-pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jan 2020 (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.
A multicenter randomized, single blind, active comparator controlled phase 2 study which is to evaluate the effectiveness, safety and the PK/PD characteristics of different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance therapy in the treatment of anemia in chronic renal failure patients with hemodialysis
Detailed description
This trial is a multicenter randomized, single blind, active comparator controlled phase 2 study. The study is divided into two stages. The first stage lasts for 18 weeks, and is divided into fixed dose period (day 1~ 6th week ) and dose adjustment period (7th ~ 18th week). The second stage lasts for 28 weeks, and is also divided into dose adjustment period (19th ~ 38th week) and evaluation period (39th ~ 46th week).
Patients are randomly assigned to seven study groups in the first stage. Of all these seven groups, six groups are: Group A (0.8μg/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)、Group B (1.2μg/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)、Group C (1.6μg/kg RD01, once every two weeks, subcutaneous injection, for 18 weeks)、 Group D (0.8ug/kg RD01, once every two weeks, intravenous injection, for 18 weeks)、Group E ( 150 IU/kg rHuEPO, once a week, subcutaneous injection, for 18 weeks )、Group F (8μl /kg placebo, once every two weeks, for 6 weeks; then 150 IU/kg rHuEPO, once a week, subcutaneous injection, 7th ~ 18th week ).
At the beginning of the second stage, some patients in these six goups need to be be randomized again. Of which patients in Group A、B、C are randomly assigned to Group a ( RD01, once every two weeks, subcutaneous injection, 19th ~ 46th week )、Group b (RD01, once every four weeks, subcutaneous injection, 19th ~ 46th week)、Group c (RD01, once every six weeks, subcutaneous injection, 19th ~ 46th week); Patients in Group D enter directly to Group d (RD01, once every four weeks, intravenous injection, 19th ~ 46th week); Patients in Group E and F are randomly assigned to Group e (rHuEPO once a week, intravenous injection, 19th ~ 46th week ) and Group f (rHuEPO once a week, subcutaneous injection, 19th ~ 46th week). The starting dose of the second stage for individual patient in all groups refers to the weekly dose at the end of the first stage .
During the whole study period, all patients in six groups are not allowed to adjust dosage in the first 6 weeks, while in the remaining trial period dosage adjustment was allowed once every two weeks if necessary.
There is a special Group G (1.6μg/kg RD01, once every four weeks, subcutaneous injection, Day 1 ~ 28th week), all patients are allowed to adjust dosage during the whole 28 weeks.
This phase 2 study is to evaluate the effectiveness, safety and the PK/PD characteristics of different doses, frequencies and routes of pegerythropoietin Injection (RD01) as maintenance therapy in the treatment of anemia in chronic renal failure patients with hemodialysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A +Group a | Experimental | Drug: RD01Group A: 0.8μg/kg RD01, once every two weeks, Day 1~ 18th week;Group a: refers to the weekly dose at the end of the first stage , once every two weeks, 19th~46th week |
| Experimental Group B +Group b | Experimental | Drug: RD01Group B: 1.2μg/kg RD01, once every two weeks, Day 1~ 18th week; Group b: refers to the weekly dose at the end of the first stage , once every four weeks, 19th~46th week |
| Experimental Group C +Group c | Experimental | Drug: RD01Group C: 1.6μg/kg RD01, once every two weeks, Day 1~ 18th week; Group c: refers to the weekly dose at the end of the first stage , once every six weeks, 19th~46th week |
| Experimental Group D +Group d | Experimental | Drug: RD01Group D: 0.8μg/kg RD01, once every two weeks, Day 1~ 18th week; Group d: refers to the weekly dose at the end of the first stage , once every four weeks, 19th~46th week |
| Experimental Group E +Group e | Active comparator | Drug: Recombinant Human Erythropoiesis Injection (CHO cell)Group E: 150IU/kg rHuEPO, once a weeks, subcutaneous administration, Day 1~ 18th week; Group e: refers to the weekly dose at the end of the first stage , once a weeks, intravenous administration, 19th~46th week |
| Experimental Group F +Group f | Placebo comparator | Drug: Recombinant Human Erythropoiesis Injection (CHO cell), Drug: placeboGroup F: 8μl placebo, once every two weeks, for 6 weeks; 150 IU/kg rHuEPO, once week, subcutaneous injection, 7th ~ 18th week; Group f: refers to the weekly dose at the end of the first stage , once a weeks, subcutaneous administration, 19th~46th week |
| Experimental Group G | Experimental | Drug: RD01Group G: 1.6μg/kg RD01, once every four weeks, Day 1~ 28th week; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with chronic renal failure who are undergoing maintenance hemodialysis for at least 12 weeks;
- 18 ≤ age ≤ 75 years of age, male or female;
- Patients who have received short-acting EPO treatment and meets the treatment standard (hemoglobin 100 ~ 120 g / L). The mean Hb value in the screening period (at least two weeks apart ) is within the range of 100 ~ 120 g / L (both ends). The difference is less than 10g / L;
- Evaluation of iron status during the screening period, transferrin saturation (TSAT) ≥20% or serum ferritin (SF) ≥200 μg / L;
- Evaluation of dialysis adequacy during the screening period, with SpKt / V≥1.2 or URR≥65%;
Key exclusion criteria (20 listed)
- Patients who have received or plan to have a kidney transplant during the study period
- Except of renal anemia, there are other diseases that cause chronic anemia (such as sickle cell anemia, myelodysplastic syndrome, hematological malignancies, myeloma, hemolytic anemia, pure red blood cell aplastic anemia)
- Patients with acute or chronic blood loss (such as upper gastrointestinal bleeding) in the past 3 months or patients who have undergone surgery with extensive bleeding, or patients who plan to undergo surgery during the study period
- Patients with coagulation dysfunction (time to activate partial thromboplastin> 1.5 times the upper limit of normal value)
- The following circumstances (including but not limited to) during the screening, investigators evaluated that it is not suitable for enrollment:
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 |
|---|---|---|
| RD01Also: pegerythropoietin InjectionRD01 is a PEGylated recombinant human erythropoietin with the same biological effects as natural erythropoietin | Drug | Experimental Group A +Group a, Experimental Group B +Group b, Experimental Group C +Group c, Experimental Group D +Group d, Experimental Group G |
| Recombinant Human Erythropoiesis Injection (CHO cell)Also: rHuEPOrHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin | Drug | Experimental Group E +Group e, Experimental Group F +Group f |
| placeboplacebo | Drug | Experimental Group F +Group f |
Primary outcome
Primary efficacy index : The change of hemoglobin concentration of experimental group from baseline to the end of 4th and 6th week
Time frame: Day 1~4th week & Day 1~6th week
Primary efficacy index: The difference of hemoglobin concentration between the experimental group and the placebo group at the end of 4th and 6th week;
Time frame: Day 1~4th week & Day 1~6th week
Primary efficacy index: hemoglobin concentration change from baseline to the end of first stage
Time frame: Day 1~18th week
The amount of change in hemoglobin concentration from baseline to the end of the first stage
Primary efficacy index: hemoglobin concentration change from baseline to the evaluation periods in the second stage (39th ~46th week)
Time frame: Day 1~ evaluation periods (39th ~46th week)
The amount of change in hemoglobin concentration from baseline to the evaluation periods in the second stage (39th ~46th week).
9 secondary outcomes
Secondary efficacy index: the optimal dosage
Time frame: the end of 18th week & 39th ~46th week
Secondary efficacy index: maintenance rate
Time frame: 39th-46th week
Secondary efficacy index : Proportion of subjects with unstable Hb during the evaluation period
Time frame: 39th-46th week
Secondary efficacy index: proportion of times of Hb remains within the target range
Time frame: 39th-46th week
Secondary efficacy index: EPO dose conversion coefficient of RD01
Time frame: end of 18th week & 39th ~46th week
Safety indicator: adverse events
Time frame: for 46 weeks
Immunogenicity indicator: incidence of anti-RD01 antibodies
Time frame: for 46 weeks
Maximum Plasma Concentration (Cmax)
Time frame: for 46 weeks
Area Under the Curve (AUC)
Time frame: for 46 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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 RD01 and Recombinant Human Erythropoiesis Injection (CHO cell) in people with Patient of Anemia in Chronic Renal Failure With Hemodialysis, run by Shengzhen Sciprogen Bio-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 20 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 18 Jan 2020. 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. 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 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 Gengru Jiang, Medical PhD (13816238339, jianggeng-ru@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy index : The change of hemoglobin concentration of experimental group from baseline to the end of 4th and 6th week (time frame: Day 1~4th week & Day 1~6th week). The study lists 4 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 18 Jan 2020.