An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

NCT01318512 | Completed Results

• 1 other identifier: ML25317
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.

Conditions

Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (11)

• Average Dose of MIRCERA at Entry Level

  The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.

  Baseline

• Average Dose of MIRCERA During Titration Period Month 1

  The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.

  Month 1

• Average Dose of MIRCERA During Titration Period Month 2

  The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

  Month 2

• Average Dose of MIRCERA During Titration Period Month 3

  The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

  Month 3

• Average Dose of MIRCERA During Titration Period Month 4

  The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

  Month 4

• Average Dose of MIRCERA During Maintenance Period Month 1

  The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  Month 5 (Maintenance Period Month 1)

• Average Dose of MIRCERA During Maintenance Period Month 2

  The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  Month 6 (Maintenance Period Month 2)

• Average Dose of MIRCERA During Maintenance Period Month 3

  The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  Month 7 (Maintenance Period Month 3)

• Average Dose of MIRCERA During Maintenance Period Month 4

  The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  Month 8 (Maintenance Period Month 4)

• Average Dose of MIRCERA During Maintenance Period Month 5

  The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  Month 9 (Maintenance Period Month 5)

• Average Dose of MIRCERA During Maintenance Period Month 6

  The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  Month 10 (Maintenance Period Month 6)

Secondary Outcomes (2)

• The Mean Hemoglobin (Hb) Level During Titration Period

  Baseline, Month 1, 2, 3, 4

• The Mean Hemoglobin (Hb) Level During Maintenance Period

  Month 5, 6, 7, 8, 9, 10

Study Arms (1)

Chronic Kidney Disease

Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of haemoglobin.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic kidney disease receiving Mircera treatment

You may qualify if:

• Adults patients, \>/=18 years of age
• Presence of chronic kidney disease (Stage 3-4)

You may not qualify if:

• Participation in another clinical study

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Nemocnice Novy Jicin; Dialyzacni Stredisko

Nový Jičín, 741 11, Czechia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 18, 2011
• Study Start: July 31, 2010
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: July 5, 2017
• Results First Posted: December 3, 2015

Record last verified: 2017-05

Locations

CZ (1)