Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients

NCT03408639 | Completed Phase 3 Results DMC

• 2 other identifiers: ERY.CIN.MA.94IRCT201601156135N6
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 8

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 alpha) on the treatment of anemia in 156 End-Stage Renal Disease hemodialysis patients. 156 patients have been planned to randomize and assign to receive CinnaPoietin® or Eprex® for a 26-week period. Administration dose for patients who are treated with erythropoietin is the similar dose of the previously administered amount (IV or SC without any change). After then, dose adjustment will be made based on patients' response. The primary objective of this study is to compare the efficacy of CinnaPoietin® with Eprex®. The secondary objectives of this study are further comparison and evaluation of efficacy along with safety between CinnaPoietin® and Eprex®.

Conditions

Anemia in End-Stage Renal Disease

Keywords

End-Stage Renal Disease, Anemia, Erythropoietin, Hemoglobin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• The Proportion of Patients With Any Permanent or Transient Dose Change

  26 weeks

• The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)

  26 weeks

• The Proportion of Patients Needed Blood Transfusions

  26 weeks

• The Proportion of Patients With Treatment Success

  Week 12 to week 26

• The Proportion of Patients With Maintenance Success

  26 weeks

Study Arms (2)

CinnaPoietin®

EXPERIMENTAL

The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.

Drug: CinnaPoietin®; Drug: Nephrovit; Drug: Vitamin B12 Injection

Eprex®

ACTIVE COMPARATOR

The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response. In addition to main intervention, Nephrovit tablet/day and vitamine B12 100 mcg/month will be prescribed for patients.

Drug: Eprex®; Drug: Nephrovit; Drug: Vitamin B12 Injection

Interventions

CinnaPoietin® DRUG

The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.

Also known as: Beta erythropoietin

CinnaPoietin®

Eprex® DRUG

The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.

Also known as: Epoetin alpha

Eprex®

Nephrovit DRUG

Nephrovit tablet is daily administered to all the patients.

CinnaPoietin®; Eprex®

Vitamin B12 Injection DRUG

Vitamin B12 is monthly injected to all the patients.

CinnaPoietin®; Eprex®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cinnagen: lead

Study Sites (8)

Javad-al-Aemeh clinic

Kerman, Iran

Location

SHAFA Hospital

Kerman, Iran

Location

Haj Ebrahimi dialysis center

Shiraz, Iran

Location

Ghiasi hospital

Tehran, Iran

Location

Hashemi Nezhad Hospital

Tehran, Iran

Location

Imam Hussein Hospital

Tehran, Iran

Location

Madar dialysis center

Tehran, Iran

Location

Milad Hospital

Tehran, Iran

Location

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MeSH Terms

Conditions

Kidney Failure, Chronic; Anemia

Interventions

Epoetin Alfa; Vitamin B 12

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Nassim Anjidani
• Organization: CinnaGen Co.

Anjidani.N@orchidpharmed.com

00989125477964

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: January 24, 2018
• Study Start: June 22, 2016
• Primary Completion: July 19, 2017
• Study Completion: July 19, 2017
• Last Updated: December 18, 2019
• Results First Posted: November 6, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (8)