Status:
COMPLETED
Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients
Lead Sponsor:
Cinnagen
Conditions:
Anemia in End-Stage Renal Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This Phase III, randomized, two-armed, parallel, double-blind, active-controlled clinical trial is designed to compare efficacy and safety of CinnaPoietin® (Beta erythropoietin) and Eprex® (epoetin al...
Detailed Description
This study is a phase III, randomized, two-armed, parallel, double-blind (patient and assessor blinded), active-controlled noninferiority clinical trial to determine the non-inferior therapeutic effic...
Eligibility Criteria
Inclusion
- Aged between 18 and 70
- ESRD patients who are on hemodialysis for ≥3 months.
- Hb level 8- 11.5 g/dl
- Patients are on adequate hemodialysis: the minimally adequate dose of hemodialysis given 3 times per week should be a spKt/V (single-pool delivered Kt/V; clearance of urea x dialysis time/volume of distribution) of 1.2 per dialysis. For treatment periods of less than 5 hours, an alternative minimum dose is a urea reduction rate (URR) of 65%. All types of hemodialysis systems and hemodiafiltration, including high-flux membranes are allowed as long as there is no plan to change the patient's regimen during the study.
- Sufficient iron stores, defined as serum ferritin ≥ 200 ng/ml and transferrin saturation ≥20%. (Patients not meeting these criteria may receive iron supplementation therapy during the Screening and stabilization period to appropriately correct their iron store deficiency to meet the criterion required for randomization);
- Ability to comply with study medication use, study visits, and study procedures as judged by the investigator;
- Females of childbearing potential agree to use an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) for the duration of the study.
- Qualified and willing to sign the informed consent form with the commitment of complying with all the scheduled visits, and study procedures as judged by the investigator;
- In any circumstances that potential participants are not able to give consent, it may be given by responsible parents or guardian.
Exclusion
- Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure ≥ 100 mmHg or systolic blood pressure ≥180 mmHg);
- Anemia secondary to other causes different to the CKD (e.g. multiple myeloma, aplastic anemia, leukemia;….)
- Decompensated liver failure;
- Clinical evidence of concurrent uncontrolled hyperparathyroidism (defined as serum parathyroid hormone (iPTH) \> 800 pg/ml);
- Heart failure \[New York Heart Association (NYHA) class III and IV\];
- Unstable angina pectoris, active cardiac disease, stroke and/or cardiac infarction within the last 6 months;
- History of or active blood coagulation disorders including DVT, PTE, native access Thrombosis during last 6 months.
- Thrombocytosis (platelet count \> 500,000/µl);
- Thrombocytopenia (platelet count \< 100,000/µl);
- White blood cell count \< 3,000/µl);
- White blood cell count \>15,000/µl)
- Recent Bleeding (acute or chronic bleeding within three months prior to screening);
- Suspicion of or confirmed occult bleeding (increased reticulocyte count);
- Clinical evidence of concurrent systemic infection, or inflammatory disease (e.g; diabetic foot, bed sore, access infection, CRP\> 30 mg/l,…)
- Currently receiving treatment for epilepsy;
- Major surgery within 3 months prior to randomization and during the conduct of the trial (except vascular access surgery);
- Concomitant immunosuppressive therapy; patients on a short course of steroids (up to 7 days), topical or intranasal steroids are allowed in the study;
- History of any malignant disease within the last 5 years (except excised non-melanoma skin cancer);
- Women who are pregnant or breastfeeding;
- Known history of severe drug-related allergies;
- Known history of drug related allergy to Erythropoietin or one of the ingredients of the test or the reference products or hypersensitivity to mammalian-derived products;
- Transplant received within one year prior to the start of the study;
- Simultaneous participation in another clinical study or having received an Investigational Medicinal Product within three months before randomization in this study.
- Psychiatric, addictive (drugs or alcohol) or any other disorder that compromises the ability to give an informed consent;
- Any red blood cell transfusion during the last 3 months (measured at the time of eligibility verification);
- Primary hematological disorder (e.g. myelodysplastic syndrome, myeloma, sickle cell anemia, hematological malignancy, multiple myeloma hemolytic anemia);
- known resistance to the rHuEPO defined by a requirement \> 450 IU/kg/week by IV or 300 IU/kg/week by SC, equivalent to approximately 20.000 IU/week SC and in absence of iron deficiency;
- who have suffered an event of active bleeding in the 30 days prior to the beginning of the study;
- Morbid obesity, defined by a Body Mass Index (BMI) \> 37 kg/m2 in women and \> 40 kg/m2 in men.
Key Trial Info
Start Date :
June 22 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2017
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03408639
Start Date
June 22 2016
End Date
July 19 2017
Last Update
December 18 2019
Active Locations (8)
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1
Javad-al-Aemeh clinic
Kerman, Iran
2
SHAFA Hospital
Kerman, Iran
3
Haj Ebrahimi dialysis center
Shiraz, Iran
4
Ghiasi hospital
Tehran, Iran