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A Phase III, randomized, two armed, multicenter, parallel, double blind (patient and assessor blinded), active controlled non inferiority clinical trial to determine the non inferior therapeutic efficacy and safety between Beta erythropoietin ®(CinnaPoietin) and Eprex® (epoetin alpha) on treatment of anemia in End stage renal disease (ESRD) hemodialysis patients

Protocol summary

Summary
The study is designed as phase III, randomized, two armed, multicenter, parallel, double blind (patient and assessor blinded), active controlled non inferiority clinical trial with primary outcomes of mean hemoglobin level change and the mean weekly epoetin dosage per kg body weight in anemic patients with End stage renal disease (ESRD ) under hemodialysis to assess the non inferiority effect of CinnaPoietin® (Beta erythropoietin) compared with Eprex® (epoetin alpha) in correction of hemoglobin level. Participants include 18 to 70 years old ESRD patients who are on hemodialysis for ≥3 months with Hb level 8- 11.5 g/dl on adequate hemodialysis (more details have been described in eligibility criteria section). The treatment proposed in this study was elaborated according to the KDIGO guidelines. Before the beginning of the protocol, for the patient to be able to enter the treatment, it shall be controlled that the iron (Fe) stores are adequate. In addition to main intervention, Nephrovit tablet /daily and B12 100 mcg (Amp)/monthly will be Will be prescribed for each patient. Pre-intervention treatment with iron will be of interest to reach a transferrin saturation percentage (TSAT) ≥ 20% and a ferritin ≥ 200ng/ml. In Cinnapoeitin group, the starting dose is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropetin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients’ response. All the procedures and interventions in Eprex® (epoetin alpha) group will be conducted as CinnaPoietin® group, fully described above. Mean Hb change level during the last 4 weeks of treatment and the mean weekly epoetin dosage per kg body weight during the last 4 weeks of treatment necessary to maintain the Hb level within 10-12 g/dl will be considered as primary endpoints. Patients will be followed for 26 weeks and visited every two weeks every two weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201601156135N6
Registration date: 2016-01-17, 1394/10/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
Hamed Hosseini
Name of organization / entity
Clinical Trial Center (CTC),Tehran University of Medical Sciences (TUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 3546
Email address
hhosseini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
CinnaGen Pharmaceutical Company
Expected recruitment start date
2016-03-01, 1394/12/11
Expected recruitment end date
2017-08-11, 1396/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Phase III, randomized, two armed, multicenter, parallel, double blind (patient and assessor blinded), active controlled non inferiority clinical trial to determine the non inferior therapeutic efficacy and safety between Beta erythropoietin ®(CinnaPoietin) and Eprex® (epoetin alpha) on treatment of anemia in End stage renal disease (ESRD) hemodialysis patients
Public title
CinnaPoietin® versus Eprex® on treatment of anemia in End stage renal disease (ESRD ) hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
• 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); • who present iron stores according to the KDIGO guidelines; • 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 Criteria: • 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 myoloma, 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 six months; • History of or active blood coagulation disorders including DVT, PTE, native access Thrombosis during last six 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) • 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,…) • 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.
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 156
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
TUMS Ethic Committee, 6th floor, Central Building, Ghods st, Keshavarz Blvd, Teahran, Iran
City
Tehran
Postal code
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.TUMS.MED.REC.1394.969

2

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz, Iran.
City
Shiraz
Postal code
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.SUMS.MED.REC.1394.s50

Health conditions studied

1

Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease

Primary outcomes

1

Description
• mean Hb change level during the last 4 weeks of treatment
Timepoint
during 26 weeks every 2 week
Method of measurement
CBC test

2

Description
mean weekly epoetin dosage per kg body weight during the last 4 weeks of treatment
Timepoint
during 26 weeks every 2 week
Method of measurement
Total dose administered

Secondary outcomes

1

Description
Proportion of patients with any permanent or transient dose change during main study phase
Timepoint
during 26 weeks every 2 week
Method of measurement
any dose change

2

Description
proportion of patients with any Hb measurement outside the target range
Timepoint
during 26 weeks every 2 week
Method of measurement
CBC test

3

Description
incidence of blood transfusions
Timepoint
during 26 weeks follow up
Method of measurement
count of blood transfusion event

4

Description
Proportion of patients with treatment success
Timepoint
during 26 weeks every 2 week
Method of measurement
Hb concentration≥11.0 g/dl or two consecutive weeks without any blood transfusion within the preceding 3 months

5

Description
The incidence of Hb levels above 13 g/dL
Timepoint
during 26 weeks every 2 week
Method of measurement
CBC test

6

Description
Proportion of patients with an increase in Hb concentration of > 1.0 g/dL for 4 weeks
Timepoint
during 26 weeks every 2 week
Method of measurement
CBC test

Intervention groups

1

Description
In Cinnapoeitin group, the starting dose is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropetin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients’ response.
Category
Treatment - Drugs

2

Description
In Eprex group, the starting dose is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropetin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients’ response.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghiasi Hospital
Full name of responsible person
Mohammad Reza Abbasi
Street address
Rejaei st., Banaei, Valiasr, YaftAbad
City
Tehran

2

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Jalal Azmandian
Street address
Shafa St., Kerman
City
Kerman

3

Recruitment center
Name of recruitment center
Hashemi Nejad Hospital, Iran University of Medical Sciences
Full name of responsible person
Shahrzad Ossareh ; Hooshang Sanadgol
Street address
Iran University of Medical Sciences, Vanak sq., Tehran 1969714713-Iran
City
Tehran

4

Recruitment center
Name of recruitment center
Emam Hosein Hospital
Full name of responsible person
Dr. Amir Ahmad Nasiri
Street address
Emam hossein hospital, Madani St.,Tehran
City
Tehran

5

Recruitment center
Name of recruitment center
MADAR dialysis center
Full name of responsible person
Dr. Amir Ahmad Nasiri
Street address
MADAR dialysis center, 58th street, Sani St., Tehran.
City
Tehran

6

Recruitment center
Name of recruitment center
Javad-al-Aemeh clinic
Full name of responsible person
Dr. Jalal Azmandian
Street address
Javad-al-Aemeh hospital, Alley number 25, North Abuzar Street
City
Kerman

7

Recruitment center
Name of recruitment center
Haj ebrahimi dialysis center
Full name of responsible person
Street address
Haj ebrahimi dialysis center, Sadra town, Shiraz
City
Shiraz

8

Recruitment center
Name of recruitment center
Milad Hospital
Full name of responsible person
Vahid Pourfarziani
Street address
Department of nephrology, Milad Hospital, Hemmat Exp. Way, Tehran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
CinnaGen Pharmaceutical Company
Full name of responsible person
Somayeh Amini
Street address
No.2 , 7thSt., Simaye Iran St., Shahrak Gharb, Tehran, IRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CinnaGen Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Orchidpharmed company
Full name of responsible person
Dr.somayeh Amini
Position
Medical Manager, Pharm.D
Other areas of specialty/work
Street address
No.2 , 7thSt., Simaye Iran St., Shahrak Gharb, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
146699874
Phone
00982188088821
Fax
00982188088821
Email
amini.s@orchidpharmed.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Orchidpharmed company
Full name of responsible person
Somayeh Amini
Position
Medical Manager, Pharm.D
Other areas of specialty/work
Street address
No.2 , 7thSt., Simaye Iran St., Shahrak Gharb, Tehran, IRAN
City
Tehran
Postal code
146699874
Phone
+98 21 8808 8821
Fax
+98 21 8856 1575
Email
amini@orchidpharmed.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Orchidpharmed
Full name of responsible person
Sima Sasanfar
Position
Clinical Trial Manager, Pharm.D
Other areas of specialty/work
Street address
No.2 , 7thSt., Simaye Iran St., Shahrak Gharb, Tehran, IRAN
City
Tehran
Postal code
146699874
Phone
+98 21 42815
Fax
+98 21 8856 2889
Email
sasanfar.s@orchidpharmed.com>
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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