OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis

Anemia Clinical Trial

— OPTIMA  

Official title:

An Observational, Prospective Study to Evaluate the Hemoglobin Levels in Non-Dialysis Chronic Kidney Disease Subjects With Renal Anemia, Treated With MIRCERA (Methoxy-Polyethylene-Glycol-Epoetin Beta)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902628
• Other study ID #: ML28261
• Status: Completed
• Start date: July 15, 2013
• Est. completion date: September 4, 2016

Study information

• Verified date: August 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: September 4, 2016
• Est. primary completion date: September 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants, >/= 18 years of age

• Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 & 4)

• Initiated on Mircera treatment (participants may have received Mircera treatment for up to 3 months before study enrollment)

• Life expectancy > 10 months

Exclusion Criteria:

• Malignant disease

• Significant or acute bleeding

• Poorly controlled hypertension

• Blood transfusion during the previous 2 months

• Hypersensitivity to Mircera or any of its excipients

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Greece	Uni Hospital of Alexandroupoli; Nephrology Dept.	Alexandroupolis
Greece	General Hospital Of Athens G.Gennimatas; Nephrology	Athens
Greece	General Hospital Of West Attikis; Nephrology	Athens
Greece	Ippokrateion Gen. Hospital Of Athens; 2nd University Clinic Of Internal Medicine, Diabetes Center	Athens
Greece	Kyanos Stavros Private Hospital; Nephrologic Clinic	Athens
Greece	Laiko General Hospital; Nephrology Div.	Athens
Greece	Nikea General Hospital; Nephrologic Clinic	Athens
Greece	Red Cross Hospital;Nephrology Dpt.	Athens
Greece	University Hospital Attikon ; Pathology Clinic	Athens
Greece	General Hospital Of Dramas; Dialysis Center Unit	Drama
Greece	University Hospital Of Heraklion; Nefrologiki Clinic	Heraklion
Greece	Uni Hospital of Ioannina; Nephrology Dept.	Ioannina
Greece	General Hospital Of Katerinis; Nephrology Unit	Katerini
Greece	General Hospital of Kilkis; Nephrology	Kilkis
Greece	Univeristy Hospital of Larissa; Nephrology	Larissa
Greece	Agios Andreas General Hospital; Nephrology	Patra
Greece	Olympion Therapeytirion; Nefrology	Patra
Greece	General Hospital Tzanio ; Nephrology	Piraeus
Greece	General Hospital Of Serres; Nephrology	Serres
Greece	Agios Loukas Private Clinic; Nephrology	Thessaloniki
Greece	AXEPA Pathology Section; A Pathology Clinic	Thessaloniki
Greece	Thermi Private Clinic; Nephrology	Thessaloniki
Greece	Thessaliki Nossileytiki; Nephrology	Volos
Greece	General Hospital of Xanthi; Nephrology	Xanthi

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10	g/dL = grams per deciliter	Months 8 to 10
Secondary	Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10	g/dL = grams per deciliter	Months 8 to 10
Secondary	Percentage of Participants With MIRCERA Dose Adjustments	Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated.	Up to 10 months
Secondary	Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs	An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.	Up to 10 months