An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)

NCT01417377 | Completed Results

• 1 other identifier: ML25368
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 6

Brief Summary

This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study

  Month 4 up to Month 6

Secondary Outcomes (3)

• Time to Achieve Hb Level to 11-12 g/dL

  Up to 6 months

• Number of Dose Adjustments Required to Maintain Hb Levels

  Up to 6 months

• Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)

  Up to 6 months

Study Arms (1)

Cohort

Mircera

Drug: Mircera

Interventions

Mircera DRUG

Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months.

Cohort

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

You may qualify if:

• Adult patients, age 18 years or above
• Chronic kidney disease (CKD) with anemia
• Patients on dialysis receiving short-acting epoetin (EPO)
• Serum ferritin level \>/=100 ng/ml or transferrin saturation (TSAT) \>/=20%

You may not qualify if:

• Patients unwilling to give informed consent
• Uncontrolled hypertension
• Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
• Relevant acute or chronic bleeding history
• Hemolysis
• Hemoglobinopathies
• Pure red cell aplasia

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Sheikh Zayed Hospital; Department of Nephrology

Lahore, 20021, Pakistan

Location

Fatima Memorial Hospital; Nephrology

Lahore, 54590, Pakistan

Location

Doctor's Hospital and Medical Centre

Lahore, Pakistan

Location

Khair-un-Nisa Hospital

Lahore, Pakistan

Location

Surgimed Hospital

Lahore, Pakistan

Location

Northwest General Hospital; Department of Nephrology

Peshawar, Pakistan

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

As none of the enrolled participants in the study achieved the endpoint of maintaining Hb level between 11-12 g/dL during the final 2 months of study, therefore efficacy parameters were not analyzed.

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: August 5, 2011
• First Posted: August 16, 2011
• Study Start: May 31, 2010
• Primary Completion: March 31, 2012
• Study Completion: March 31, 2012
• Last Updated: July 13, 2017
• Results First Posted: December 9, 2015

Record last verified: 2017-05

Locations

PA (6)