Renal Insufficiency, ChronicPhase 1NCT03572647

Pharmacokinetics and Pharmacodynamics Assessment of Drug Eritromax Compared to Eprex in Healthy Subjects.

A Phase 1 study testing Eritromax and Eprex in people with Renal Insufficiency, Chronic, run by Azidus Brasil at 1 site in Brazil.

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 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Renal Insufficiency, Chronic
What is being tested?: Eritromax and Eprex
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteBrazil
Study dates: Nov 2012to May 2013
Phase: Phase 1
Are there results?: None posted in the registry

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 20 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Confirm the voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
Being male, aged between 20 and 55 years, clinically healthy;
BMI between 18 and 25;
Results of examination of hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
Results of VCM, HBMC, platelets and leukocytes within the normal range:
VCM = Between 82 to 98. Among the HBMC = 26 to 34. Among the platelets = 150,000 to 400,000 units per mL. Among the WBC = 3,500 to 10,500 units per mL and without cellular atypia.

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Serum ferritin = Male between 36 to 262 mcg / L and women between 24 to 155 mcg / L;
Reticulocyte count in peripheral blood ≤ 3%;
Serum erythropoietin less than 30 mIU / mL.

Who cannot join

Participation in clinical trials in the 12 months preceding the survey;
Presence of iron deficiency anemia;
Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
Acute disease in the period of 07 days prior to inclusion;
Chronic administration of medication to determine, such as high blood pressure;
Hormone therapy in the period of 02 months prior to inclusion;

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Administration of any drug in the 02 weeks prior to inclusion;
A history of autoimmune anemia or hereditary;
research subjects with a history of chronic bleeding;
research subjects with a history of acute bleeding in the last 30 days;
History of sensitivity to biological products derived from mammals, albumin, or any component of the formulation;
History of or current use at least 12 months of tobacco;
Current or previous history (less than 12 months) of illicit drug use;
previous therapy with erythropoietin;
albumin below 3.5 g / dl or greater than 4.8 g / dL;
Signs or clinical history of bone marrow aplasia;
History of liver disease and clinical or laboratory;
History of renal disease and clinical or laboratory.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

LAL Clínica Pesquisa e Desenvolvimento Ltda.
Valinhos, São Paulo, 13270000

Other trials in Brazil

About this study

Official title: Randomized Clinical Study for Pharmacokinetics and Pharmacodynamics Assessment of Drug Eritromax, Marketed by the Blausiegel Laboratory, Compared to Drug Eprex, Produced by Janssen-Cilag Laboratory, in Healthy Subjects.

The epoetin is a glycoprotein and endogenous hormone, which is primarily synthesized by specific epithelial cells lining the kidney peritubular capillaries, and regulates continuous formation of red blood cells. This is a pharmacokinetics and pharmacodynamics study, in which each subject will receive the investigational product in different periods, as randomisation (Teste or Comparator). The evaluation of the profile included serum dosage of medications and reticulocyte count in peripheral blood.

Read the detailed description

This a prospective randomized and crossover study for evaluation of pharmacokinetics and pharmacodynamics of two epoetins formulations. The subjects will receive in each confinement period 4000 IU one of the investigational product subcutaneously, according to randomisation, separated by a washout period of 4 weeks. The evaluation of the profile between products included serum dosage of medications and reticulocyte count in peripheral blood. Safety evaluation data will include report od all adverse events (including type, frequency, intensity, seriousness, severity and action taken related to the investigational product study).

Conditions: Renal Insufficiency, Chronic
Being tested: Eritromax, Eprex
Keywords: Erythropoeitin, Chronic kidney disease, Anaemia
Medical subject headings: Renal Insufficiency, Chronic, Anemia

What participants receive

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

EritromaxDrug
Also called epoetin alfa
The subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation.
EprexDrug
Also called epoetin alfa
The subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation.

Study groups in NCT03572647
Study group	Role	What they receive
Test ERITROMAX	Experimental	Blausiegel Industria e Comercio Ltda. Recombinant Human Erythropoietin (ERITROMAX) Receives: Drug: Eritromax
EPREX	Active comparator	Janssen-Cilag Recombinant Human Erythropoietin (EPREX) Receives: Drug: Eprex

What is being measured

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

Pharmacokinetic - rHuEPO concentration.
Will evaluated through the plasma rHuEPO dosage before and after drug administration.
Measured: Before administration (Time 0 hour) and after time 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 11 hours, 12 hours, 13 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours and 120 hours administration.
Pharmacodynamics - Absolute Reticulocyte Count.
Will evaluated through the absolute reticulocyte count at total blood.
Measured: Before administration (Time 0 hour) and after Time 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours, 240 hours and 576 hours administration.

Timeline

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

Nov 2012May 2013

First posted28 Jun 2018
Study startNov 2012
Primary completionNov 2012
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal Insufficiency, ChronicStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03572647
Sponsor's protocol ID: EPOBLA0711I
Status last verified: Nov 2022
First submitted: 3 Nov 2011
Last updated: 3 Nov 2022
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.

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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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Clinical Study for Pharmacokinetics and Pharmacodynamics Assessment of Drug Eritromax, Marketed by the Blausiegel Laboratory, Compared to Drug Eprex, Produced by Janssen-Cilag Laboratory, in Healthy Subjects.
ClinicalTrials.gov ID: NCT03572647
Acronym / sponsor ID: EPOBLA0711I
Conditions: Renal Insufficiency, Chronic
Keywords: Erythropoeitin, Chronic kidney disease, Anaemia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Azidus BrasilIndustry (pharma, biotech, devices)
Collaborators: Blau Farmaceutica S.A.
Study start: Nov 2012
Primary completion: Nov 2012 (actual)
Study completion: May 2013 (actual)
First posted: 28 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test ERITROMAX	Experimental	Drug: EritromaxBlausiegel Industria e Comercio Ltda. Recombinant Human Erythropoietin (ERITROMAX)
EPREX	Active comparator	Drug: EprexJanssen-Cilag Recombinant Human Erythropoietin (EPREX)

Who may qualify

Ages: 20 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Confirm the voluntary participation and agree to all the purposes of the study by signing and dating the IC in two ways;
Being male, aged between 20 and 55 years, clinically healthy;
BMI between 18 and 25;
Results of examination of hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
Results of VCM, HBMC, platelets and leukocytes within the normal range:

Key exclusion criteria (18 listed)

Participation in clinical trials in the 12 months preceding the survey;
Presence of iron deficiency anemia;
Presence of pulmonary diseases, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems;
Acute disease in the period of 07 days prior to inclusion;
Chronic administration of medication to determine, such as high blood pressure;

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
EritromaxAlso: epoetin alfaThe subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation.	Drug	Test ERITROMAX
EprexAlso: epoetin alfaThe subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation.	Drug	EPREX

Primary outcome

Pharmacokinetic - rHuEPO concentration.
Time frame: Before administration (Time 0 hour) and after time 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 11 hours, 12 hours, 13 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours and 120 hours administration.
Will evaluated through the plasma rHuEPO dosage before and after drug administration.
Pharmacodynamics - Absolute Reticulocyte Count.
Time frame: Before administration (Time 0 hour) and after Time 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours, 240 hours and 576 hours administration.
Will evaluated through the absolute reticulocyte count at total blood.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
Individual participant dataSharing planned: Undecided. It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data will become public.

Related trials for Renal Insufficiency, Chronic

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
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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.

Alexandre Frederico, PI principal investigator

LAL Clinica Pesquisa e Desenvolvimento Ltda

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Eritromax and Eprex in people with Renal Insufficiency, Chronic, run by Azidus Brasil at 1 site in Brazil.

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 18 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pharmacokinetic - rHuEPO concentration. (time frame: Before administration (Time 0 hour) and after time 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 11 hours, 12 hours, 13 hours, 18 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours and 120 hours administration.). 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 NCT03572647.

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 3 Nov 2022.