NCT01695759 is a Phase 3 clinical trial of Epoetin alpha in Chronic Kidney Disease, sponsored by Azidus Brasil.

Who is sponsoring NCT01695759?

NCT01695759 is sponsored by Azidus Brasil.

What drugs are being tested in NCT01695759?

Interventions in NCT01695759: Epoetin alpha, Eprex.

What condition does NCT01695759 study?

NCT01695759 studies Chronic Kidney Disease, Anemia.

Is NCT01695759 still recruiting?

NCT01695759 is currently terminated. Last updated 17 August 2018.

Last reviewed 2018-08-17 · How we verify

NCT01695759

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of Clinical Efficacy and Immunogenicity of Drug Eritromax® at Blau Farmacêutica S.A. Compared to Eprex®, Produced by Janssen-Cilag Laboratory in Participants With Secondary Anemia to Chronic Kidney Disease.

Terminated Phase 3 Last updated 17 August 2018

What this trial tests

Phase 3 trial testing Epoetin alpha in Chronic Kidney Disease in 92 participants. Terminated before completion.

Timeline

1 December 2013

Primary endpoint
1 December 2014

1 January 2018

Quick facts

Lead sponsor	Azidus Brasil
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	92
Start date	1 December 2013
Primary completion	1 December 2014
Estimated completion	1 January 2018
Sites	10 locations across Brazil

Drugs / interventions tested

Epoetin alpha — full drug profile →
Eprex — full drug profile →

Conditions studied

Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
Anemia — all drugs for Anemia →

Sponsor

Azidus Brasil — full company profile →

Who can join

Adults 18 to 70, any sex, with Chronic Kidney Disease or Anemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change of hemoglobin levels at correction phase (baseline vs end of treatment)
Time frame: until 6 months
In the correction phase, change in serum Hb levels (baseline vs. end of initial treatment (EOIT) = levels of Hb presented before the V0 treatment compared to the Hb levels presented at the end of the correction phase) will be evaluated for a maximum period of 6 months after starting treatment. This one parameter will be demonstrated through: Percentage of participants achieving Hb levels within th

Sponsor's own description

This is a prospective, randomized, multicenter, parallel, placebo-controlled, phase III study for evaluation of clinical efficacy and immunogenicity of drug Eritromax® - (rHuEPO Blau Farmacêutica S/A.) compared to Eprex® (Janssen-Cilag rHuEPO) for the treatment of patients with secondary anemia to chronic kidney disease (CKD), throughout the correction phase by assessing the change in hemoglobin levels.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Chronic Kidney Disease

Currently open trials in the same condition.

NCT07469540 — Effects of an Aerobic Exercise Program on Cardiovascular Risk in Patients With Chronic Kidney Disease or Rheumatoid Arth · NA · recruiting
NCT07169422 — Improving Kidney Care in Type 2 Diabetes: A Study of Pharmacist Prescribing Versus Usual Care · NA · recruiting
NCT07481526 — A Prospecitve Multicenter, Observational Registry Study · recruiting
NCT07450820 — OPTIMISE-CKD Study_Dapagliflozin Effectiveness in CKD · recruiting
NCT07107945 — A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease · Phase 3 · recruiting

Other Azidus Brasil trials

Trials by the same sponsor.

NCT06303635 — Safety of UFRJvac, Trivalent COVID-19 Vaccine · unknown
NCT06097780 — Efficacy and Safety of NestaCell® in Huntington's Disease · Phase 3 · unknown
NCT06150833 — Efficacy and Safety and Pharmacokinetics of Boya IVIG · Phase 3 · unknown
NCT05603403 — Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms · Phase 4 · completed
NCT05009277 — Study To Evaluate The Sensitivity Of The Linda Thermal Device · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01695759 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Azidus Brasil
Last refreshed: 17 August 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01695759.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing