| Trial ID: | L1154 |
| Source ID: | NCT03408639
|
| Associated Drug: |
Cinnapoietin®
|
| Title: |
Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03408639/results
|
| Conditions: |
Anemia in End-Stage Renal Disease
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| Interventions: |
DRUG: CinnaPoietin®|DRUG: Eprex®|DRUG: Nephrovit|DRUG: Vitamin B12 Injection
|
| Outcome Measures: |
Primary: Mean Hb Change Level During the Last Four Weeks of Treatment, The primary endpoints of this study is to assess mean Hb change level during the last four weeks of treatment., Week 22 to week 26|Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment, The mean weekly epoetin dosage per kg body weight during the last four weeks of treatment necessary to maintain the Hb level within 10-12 g/dl during the last four weeks of treatment is considered as the second primary endpoint., Week 22 to week 26 | Secondary: The Proportion of Patients With Any Permanent or Transient Dose Change, The proportion of patients with any permanent or transient dose change during 26 weeks., 26 weeks|The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl), The proportion of patients with any Hb measurement outside the target range (10-12 g/dl) during 26 weeks., 26 weeks|The Proportion of Patients Needed Blood Transfusions, The proportion of patients needed blood transfusions during 26 weeks., 26 weeks|The Proportion of Patients With Treatment Success, Treatment success is considered as Hb concentration equal to or more than 11.0 g/dl and two consecutive weeks without any blood transfusion within the preceding three months, Week 12 to week 26|The Proportion of Patients With Maintenance Success, Maintenance success is considered as maintenance success is considered as maintenance of mean Hb concentration of 11.0 ± 1.0 g/dl for at least four consecutive weeks, 26 weeks|The Percentage of Patients With Hb Measurements More Than 10.0 g/dl, The percentage of patients with Hb measurements more than 10.0 g/dl from week 22 to week 26., Week 22 to week 26|The Percentage of Patients With Hematocrit Measurements More Than 30%, The percentage of patients with hematocrit measurements more than 30% from week 22 to week 26., Week 22 to week 26|The Incidence of Hb Levels Above 13 g/dl, The first safety endpoint is the proportion of patients with at least one Hb measurement above 13 g/dL., 26 weeks|The Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks, The proportion of patients with an increase in Hb concentration of \> 1.0 g/dl for four consecutive weeks during 26 weeks., 26 weeks|The Incidence of Adverse Events, The incidence of adverse events during 26 weeks., 26 weeks
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| Sponsor/Collaborators: |
Sponsor: Cinnagen
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
|
| Enrollment: |
156
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2016-06-22
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| Completion Date: |
2017-07-19
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| Results First Posted: |
2019-11-06
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| Last Update Posted: |
2019-12-18
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| Locations: |
Javad-al-Aemeh clinic, Kerman, Iran, Islamic Republic of|SHAFA Hospital, Kerman, Iran, Islamic Republic of|Haj Ebrahimi dialysis center, Shiraz, Iran, Islamic Republic of|Ghiasi hospital, Tehran, Iran, Islamic Republic of|Hashemi Nezhad Hospital, Tehran, Iran, Islamic Republic of|Imam Hussein Hospital, Tehran, Iran, Islamic Republic of|Madar dialysis center, Tehran, Iran, Islamic Republic of|Milad Hospital, Tehran, Iran, Islamic Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT03408639
|
