Anemia in End-Stage Renal DiseasePhase 3NCT03408639

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

A Phase 3 study testing CinnaPoietin®, Eprex® and Nephrovit in people with Anemia in End-Stage Renal Disease, run by Cinnagen at 8 sites in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Anemia in End-Stage Renal Disease
What is being tested?: CinnaPoietin®, Eprex® and Nephrovit
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 156 participants
Where: 8 sitesIran
Study dates: 22 Jun 2016to 19 Jul 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Show all 9Show fewer

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.

Who cannot join

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;

Show all 29Show fewer

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Iran8 sites

Javad-al-Aemeh clinic
Kerman
SHAFA Hospital
Kerman
Haj Ebrahimi dialysis center
Shiraz
Ghiasi hospital
Tehran
Hashemi Nezhad Hospital
Tehran
Imam Hussein Hospital
Tehran
Madar dialysis center
Tehran
Milad Hospital
Tehran

Other trials in Iran

About this study

Official title: A Phase III, Randomized, Two Armed, Parallel, Double Blind (Patient and Assessor Blinded), Active Controlled Non Inferiority Clinical Trial to Determine the Non Inferior Therapeutic Efficacy and Safety Between CinnaPoietin® (Beta Erythropoietin) and Eprex® (Epoetin Alpha) on the Treatment of Anemia in ESRD Hemodialysis Patients

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®.

Read the 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 efficacy and safety between CinnaPoietin® (Beta erythropoietin) and Eprex® (epoetin alpha) on the treatment of anemia in ESRD patient under hemodialysis. After signing the written informed consents, 156 patients have been planned to randomize and assign to receive CinnaPoietin® or Eprex® for a 26-weeks 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. In addition to main intervention, Nephrovit tablet/day and B12 100 mcg/month were prescribed for patients. 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 and safety.

The clinical trial will be conducted according to the GCP considerations. A comprehensive validation check program is used to verify the data, and discrepancy reports are generated accordingly for resolution by the investigator.

In order to ensure the use of standard and unified procedure of each test, monitoring of each site and laboratory site are going to be applied by sponsor monitoring team and CRO as external monitoring team.

The same prefilled syringe is used for CinnaPoietin® to be sure that there is no difference between CinnaPoietin® and Eprex® as brand drug. The drugs will be relabeled, and the same label is used for both prefilled syringe. So neither investigators nor subjects are able to notice any differences between them and are blind to the assignment.

Determination of sample size 156 patients will be equally (1:1) divided into intervention arms (78 in each group considering drop out) for achieving 80% power in order to determine non-inferiority using a one-sided, independent sample t-test. The margin of non-inferiority is -1.00.

The true difference between the means is assumed to be -0.500. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 1.200 and 1.200.

Conditions: Anemia in End-Stage Renal Disease
Being tested: CinnaPoietin®, Eprex®, Nephrovit, Vitamin B12 Injection
Keywords: End-Stage Renal Disease, Anemia, Erythropoietin, Hemoglobin
Medical subject headings: Kidney Failure, Chronic, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CinnaPoietin®Drug
Also called Beta erythropoietin
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.
Eprex®Drug
Also called Epoetin alpha
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.
NephrovitDrug
Nephrovit tablet is daily administered to all the patients.
Vitamin B12 InjectionDrug
Vitamin B12 is monthly injected to all the patients.

Study groups in NCT03408639
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Eprex®; Drug: Nephrovit; Drug: Vitamin B12 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Week 22 to week 26

Secondary outcomes (10)

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.
Measured: 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.
Measured: 26 weeks
The Proportion of Patients Needed Blood Transfusions
The proportion of patients needed blood transfusions during 26 weeks.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 26 weeks
The Incidence of Adverse Events
The incidence of adverse events during 26 weeks.
Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 201619 Jul 2017

First posted24 Jan 2018
Study start22 Jun 2016
Primary completion19 Jul 2017
Study completion19 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (37)Papers the sponsor has linked to this study.
Other trials for Anemia in End-Stage Renal DiseaseStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03408639
Sponsor's protocol ID: ERY.CIN.MA.94
Other IDs: IRCT201601156135N6
Status last verified: Dec 2019
First submitted: 12 Dec 2017
Last updated: 18 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (1988-1994). Arch Intern Med. 2002 Jun 24;162(12):1401-8. doi: 10.1001/archinte.162.12.1401.
PubMed 12076240
McLean E, Cogswell M, Egli I, Wojdyla D, de Benoist B. Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System, 1993-2005. Public Health Nutr. 2009 Apr;12(4):444-54. doi: 10.1017/S1368980008002401. Epub 2008 May 23.
PubMed 18498676
Brittin GM, Brecher G, Johnson CA, Elashoff RM. Stability of blood in commonly used anticoagulants. Use of refrigerated blood for quality control of the Coulter Counter Model S. Am J Clin Pathol. 1969 Dec;52(6):690-4. doi: 10.1093/ajcp/52.6.690. No abstract available.
PubMed 4982112
Locatelli F, Aljama P, Barany P, Canaud B, Carrera F, Eckardt KU, Horl WH, Macdougal IC, Macleod A, Wiecek A, Cameron S; European Best Practice Guidelines Working Group. Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant. 2004 May;19 Suppl 2:ii1-47. doi: 10.1093/ndt/gfh1032. No abstract available.
PubMed 15206425
Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
PubMed 15758012
Fehr T, Ammann P, Garzoni D, Korte W, Fierz W, Rickli H, Wuthrich RP. Interpretation of erythropoietin levels in patients with various degrees of renal insufficiency and anemia. Kidney Int. 2004 Sep;66(3):1206-11. doi: 10.1111/j.1523-1755.2004.00880.x.
PubMed 15327419
Ross RP, McCrea JB, Besarab A. Erythropoietin response to blood loss in hemodialysis patients in blunted but preserved. ASAIO J. 1994 Jul-Sep;40(3):M880-5. doi: 10.1097/00002480-199407000-00122.
PubMed 8555638
Lipschitz DA, Cook JD, Finch CA. A clinical evaluation of serum ferritin as an index of iron stores. N Engl J Med. 1974 May 30;290(22):1213-6. doi: 10.1056/NEJM197405302902201. No abstract available.
PubMed 4825851
Rambod M, Kovesdy CP, Kalantar-Zadeh K. Combined high serum ferritin and low iron saturation in hemodialysis patients: the role of inflammation. Clin J Am Soc Nephrol. 2008 Nov;3(6):1691-701. doi: 10.2215/CJN.01070308. Epub 2008 Oct 15.
PubMed 18922994
Fernandez-Rodriguez AM, Guindeo-Casasus MC, Molero-Labarta T, Dominguez-Cabrera C, Hortal-Casc n L, Perez-Borges P, Vega-Diaz N, Saavedra-Santana P, Palop-Cubillo L. Diagnosis of iron deficiency in chronic renal failure. Am J Kidney Dis. 1999 Sep;34(3):508-13. doi: 10.1016/s0272-6386(99)70079-x.
PubMed 10469862
Kalantar-Zadeh K, Hoffken B, Wunsch H, Fink H, Kleiner M, Luft FC. Diagnosis of iron deficiency anemia in renal failure patients during the post-erythropoietin era. Am J Kidney Dis. 1995 Aug;26(2):292-9. doi: 10.1016/0272-6386(95)90649-5.
PubMed 7645533
Aljama P, Ward MK, Pierides AM, Eastham EJ, Ellis HA, Feest TG, Conceicao S, Kerr DN. Serum ferritin concentration: a reliable guide to iron overload in uremic and hemodialyzed patients. Clin Nephrol. 1978 Sep;10(3):101-4.
PubMed 699405
Barany P, Eriksson LC, Hultcrantz R, Pettersson E, Bergstrom J. Serum ferritin and tissue iron in anemic dialysis patients. Miner Electrolyte Metab. 1997;23(3-6):273-6.
PubMed 9387132
Blumberg AB, Marti HR, Graber CG. Serum ferritin and bone marrow iron in patients undergoing continuous ambulatory peritoneal dialysis. JAMA. 1983 Dec 23-30;250(24):3317-9.
PubMed 6645029
Hussein S, Prieto J, O'Shea M, Hoffbrand AV, Baillod RA, Moorhead JF. Serum ferritin assay and iron status in chronic renal failure and haemodialysis. Br Med J. 1975 Mar 8;1(5957):546-8. doi: 10.1136/bmj.1.5957.546.
PubMed 49205

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Chronic Kidney Disease, Renal Anemia
Not yet recruitingPhase 2
Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.
Anemia
Recruiting
Studies on Adsorption International Learning Initiative Global
CKD (Chronic Kidney Disease) Stage 5D, Uremia; Chronic
Not yet recruitingPhase 4
Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia
Anemia, Kidney Failure

All Anemia in End-Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Two Armed, Parallel, Double Blind (Patient and Assessor Blinded), Active Controlled Non Inferiority Clinical Trial to Determine the Non Inferior Therapeutic Efficacy and Safety Between CinnaPoietin® (Beta Erythropoietin) and Eprex® (Epoetin Alpha) on the Treatment of Anemia in ESRD Hemodialysis Patients
ClinicalTrials.gov ID: NCT03408639
Acronym / sponsor ID: ERY.CIN.MA.94
Conditions: Anemia in End-Stage Renal Disease
Keywords: End-Stage Renal Disease, Anemia, Erythropoietin, Hemoglobin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: CinnagenIndustry (pharma, biotech, devices)
Study start: 22 Jun 2016 (actual)
Primary completion: 19 Jul 2017 (actual)
Study completion: 19 Jul 2017 (actual)
First posted: 24 Jan 2018 (actual)
Results: Posted 6 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The true difference between the means is assumed to be -0.500. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 1.200 and 1.200.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CinnaPoietin®	Experimental	Drug: CinnaPoietin®, Drug: Nephrovit, Drug: Vitamin B12 InjectionThe 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.
Eprex®	Active comparator	Drug: Eprex®, Drug: Nephrovit, Drug: Vitamin B12 InjectionThe 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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);

Key exclusion criteria (29 listed)

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];

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
CinnaPoietin®Also: Beta erythropoietinThe 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.	Drug	CinnaPoietin®
Eprex®Also: Epoetin alphaThe 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.	Drug	Eprex®
NephrovitNephrovit tablet is daily administered to all the patients.	Drug	CinnaPoietin®, Eprex®
Vitamin B12 InjectionVitamin B12 is monthly injected to all the patients.	Drug	CinnaPoietin®, Eprex®

Primary outcome

Mean Hb Change Level During the Last Four Weeks of Treatment
Time frame: Week 22 to week 26
The primary endpoints of this study is to assess mean Hb change level during the last four weeks of treatment.
Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment
Time frame: Week 22 to week 26
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.

10 secondary outcomes

The Proportion of Patients With Any Permanent or Transient Dose Change
Time frame: 26 weeks
The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)
Time frame: 26 weeks
The Proportion of Patients Needed Blood Transfusions
Time frame: 26 weeks
The Proportion of Patients With Treatment Success
Time frame: Week 12 to week 26
The Proportion of Patients With Maintenance Success
Time frame: 26 weeks
The Percentage of Patients With Hb Measurements More Than 10.0 g/dl
Time frame: Week 22 to week 26
The Percentage of Patients With Hematocrit Measurements More Than 30%
Time frame: Week 22 to week 26
The Incidence of Hb Levels Above 13 g/dl
Time frame: 26 weeks
The Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks
Time frame: 26 weeks
The Incidence of Adverse Events
Time frame: 26 weeks

Results and safety

Results posted to the registry on 6 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CinnaPoietin®	78	67
Eprex®	78	56

Primary outcome: Mean Hb Change Level During the Last Four Weeks of Treatment

Time frame: Week 22 to week 26. Mean (Standard Deviation). Unit: g/dL

Measure	CinnaPoietin® n = 61	Eprex® n = 38
Value	0.4 (1.26)	0.74 (1.39)

Primary outcome: Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment

Time frame: Week 22 to week 26. Mean (Standard Deviation). Unit: IU/Kg/week

Measure	CinnaPoietin® n = 46	Eprex® n = 19
Value	117.02 (54.5)	110.01 (49.27)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 26 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CinnaPoietin®	14 of 78 (17.9%)	11 of 78 (14.1%)	5 of 78
Eprex®	7 of 78 (9%)	12 of 78 (15.4%)	5 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12076240Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (1988-1994). Arch Intern Med. 2002 Jun 24;162(12):1401-8. doi: 10.1001/archinte.162.12.1401.
Background: PubMed 18498676McLean E, Cogswell M, Egli I, Wojdyla D, de Benoist B. Worldwide prevalence of anaemia, WHO Vitamin and Mineral Nutrition Information System, 1993-2005. Public Health Nutr. 2009 Apr;12(4):444-54. doi: 10.1017/S1368980008002401. Epub 2008 May 23.
Background: PubMed 4982112Brittin GM, Brecher G, Johnson CA, Elashoff RM. Stability of blood in commonly used anticoagulants. Use of refrigerated blood for quality control of the Coulter Counter Model S. Am J Clin Pathol. 1969 Dec;52(6):690-4. doi: 10.1093/ajcp/52.6.690. No abstract available.
Background: PubMed 15206425Locatelli F, Aljama P, Barany P, Canaud B, Carrera F, Eckardt KU, Horl WH, Macdougal IC, Macleod A, Wiecek A, Cameron S; European Best Practice Guidelines Working Group. Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant. 2004 May;19 Suppl 2:ii1-47. doi: 10.1093/ndt/gfh1032. No abstract available.
Background: PubMed 15758012Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
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Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CinnaPoietin®, Eprex® and Nephrovit in people with Anemia in End-Stage Renal Disease, run by Cinnagen at 8 sites in Iran.

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 9 inclusion and 29 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: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Iran. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Hb Change Level During the Last Four Weeks of Treatment (time frame: Week 22 to week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03408639, which also lists 37 linked publications.

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 18 Dec 2019.