Chronic Renal FailurePhase 1NCT02356419
rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics
A Phase 1 study testing Recombinant erythropoietin stimulating protein in people with Chronic Renal Failure, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
The study is a single center and open test, and the dose of successive incremental method was taken. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Recombinant erythropoietin stimulating protein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Mar 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-40 years old, male or female
- Subjects are previously healthy, and whose physical examinations are normal 14 days ago before the screening examination
- The BMI is 19-25Kg/m2 (BMI = weight / height2)
- Without anemia, white blood cell and platelet counts are normal
- Heart, lung, liver and kidney function are normal
- Without smoke and wine hobby
- Subjects voluntarily signing written informed consent.
Who cannot join
- Allergic constitution or previous history of allergy of biological products;
- Pregnant and lactating women;
- Female subjects only take oral contraceptive pills and plan pregnancy during the clinical trials or within 3 months after administration; male subjects whose female partners plan pregnancy during the clinical trials or within 3 months after administration;
- Female subjects received postmenopausal estrogen therapy;
- With malignant hypertension or hypertension is poorly controlled or with previous history of thromboembolic diseases and diseases of hematopoietic system
- Abnormal liver function ( AST or ALT is 2 times greater than the upper limit of the normal)
Show all 15Show fewer
- Hemoglobin is greater than or equal to 160g/L (male), 150 g/L (female)
- The percentage of reticulocytes is greater than or equal to 3%
- Serum iron protein <20ng/ml
- Subjects who donated blood 90 days before being enrolled or received a blood transfusion therapy or participate in other drug test
- subjects who received recombinant erythropoiesis stimulating protein or rHuEPO 3 months before being enrolled;
- recombinant erythropoiesis stimulating protein antibody (RESP) or endogenous erythropoietin (EPO) antibody positive;
- drugs known to have damage to some organs were given 3 months before being enrolled;
- subjects whose HBsAg, HBeAg, anti-HIV, anti-HCV and syphilis antibody are positive;
- researchers believe that other factors are not suitable for the trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, 110004
limei zhao, doctor, 8624-96615, zhaolm@sj-hospital.org
feng qiu, doctor, 8624-96615, zhaolm@sj-hospital.org
About this study
Official title: rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics for Healthy Subjects in the Phase Ⅰ Clinical Study
The study is a single center and open test, and the dose of successive incremental method was taken. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.
Read the detailed description
The study is a single center and open test, and the dose of successive incremental method was taken. The study included 4 groups that is 0.5 ug/kg, 1.0ug/kg, 2.0ug/kg and 3.0ug/kg,the pharmacokinetic data (the screening period, before administration, after administration of 15, 30, 60 minutes, fourth, 8, 12, 24, 36, 48, 72 hours, seventh, 10, 14, 21, 28 days, 10 cases in each group) were collected. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.
- Conditions
- Chronic Renal Failure
- Being tested
- Recombinant erythropoietin stimulating protein
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant erythropoietin stimulating proteinDrug
Also called Recombinant erythropoietin stimulating protein injection
Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites
| Study group | Role | What they receive |
|---|---|---|
| experimental 0.5 ug/kg | Experimental | there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein Receives: Drug: Recombinant erythropoietin stimulating protein |
| experimental 1.0ug/kg | Experimental | there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein Receives: Drug: Recombinant erythropoietin stimulating protein |
| experimental 2.0ug/kg | Experimental | there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein Receives: Drug: Recombinant erythropoietin stimulating protein |
| experimental 3.0ug/kg | Experimental | there are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein Receives: Drug: Recombinant erythropoietin stimulating protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reticulocyte counts
observe the reticulocyte counts and judge whether rESP could improve anemia
Measured: 6 months
Secondary outcomes (1)
Hemoglobin counts
observe the hemoglobin counts and judge whether rESP could improve anemia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionMar 2015 (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 Shenyang Sunshine 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Limei Zhao, doctor, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356419
- Sponsor's protocol ID
- SSS06
- Status last verified
- Feb 2015
- First submitted
- 18 Jan 2015
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rESP Medication With a Single Intravenous Administration and Dose Escalation to Explore the Tolerability ,Safety and Pharmacokinetic Characteristics for Healthy Subjects in the Phase Ⅰ Clinical Study
- ClinicalTrials.gov ID
- NCT02356419
- Acronym / sponsor ID
- SSS06
- Conditions
- Chronic Renal Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 5 Feb 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 study is a single center and open test, and the dose of successive incremental method was taken. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.
Detailed description
The study is a single center and open test, and the dose of successive incremental method was taken. The study included 4 groups that is 0.5 ug/kg, 1.0ug/kg, 2.0ug/kg and 3.0ug/kg,the pharmacokinetic data (the screening period, before administration, after administration of 15, 30, 60 minutes, fourth, 8, 12, 24, 36, 48, 72 hours, seventh, 10, 14, 21, 28 days, 10 cases in each group) were collected. In order to determine the tolerance and safety after a single intravenous injection of different doses of rESP in healthy subjects, the investigators had this trial. On the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| experimental 0.5 ug/kg | Experimental | Drug: Recombinant erythropoietin stimulating proteinthere are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein |
| experimental 1.0ug/kg | Experimental | Drug: Recombinant erythropoietin stimulating proteinthere are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein |
| experimental 2.0ug/kg | Experimental | Drug: Recombinant erythropoietin stimulating proteinthere are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein |
| experimental 3.0ug/kg | Experimental | Drug: Recombinant erythropoietin stimulating proteinthere are four groups in this study and healthy subjects of all groups receiving different doses of recombinant erythropoiesis stimulating protein |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18-40 years old, male or female
- Subjects are previously healthy, and whose physical examinations are normal 14 days ago before the screening examination
- The BMI is 19-25Kg/m2 (BMI = weight / height2)
- Without anemia, white blood cell and platelet counts are normal
- Heart, lung, liver and kidney function are normal
Key exclusion criteria (15 listed)
- Allergic constitution or previous history of allergy of biological products;
- Pregnant and lactating women;
- Female subjects only take oral contraceptive pills and plan pregnancy during the clinical trials or within 3 months after administration; male subjects whose female partners plan pregnancy during the clinical trials or within 3 months after administration;
- Female subjects received postmenopausal estrogen therapy;
- With malignant hypertension or hypertension is poorly controlled or with previous history of thromboembolic diseases and diseases of hematopoietic system
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 erythropoietin stimulating proteinAlso: Recombinant erythropoietin stimulating protein injectionRecombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites | Drug | experimental 0.5 ug/kg, experimental 1.0ug/kg, experimental 2.0ug/kg, experimental 3.0ug/kg |
Primary outcome
Reticulocyte counts
Time frame: 6 months
observe the reticulocyte counts and judge whether rESP could improve anemia
1 secondary outcome
Hemoglobin counts
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 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.
Limei Zhao, doctor principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant erythropoietin stimulating protein in people with Chronic Renal Failure, run by Shenyang Sunshine 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 15 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 5 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Limei Zhao, doctor (8624-96615, zhaolm@sj-hospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reticulocyte counts (time frame: 6 months). 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 5 Feb 2015.