A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease Not on Dialysis

Anemia Clinical Trial

Official title:

Efficacy of C.E.R.A for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV , Not on Dialysis , Treated According to Routine Clinical Practice

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01892202
• Other study ID #: ML25750
• Status: No longer available
• Phase: Phase 4
• First received: June 27, 2013
• Last updated: October 26, 2016
• Start date: February 2011
• Est. completion date: February 2011

Study information

• Verified date: October 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Director General of Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

This multicenter observational study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic renal anemia according to the standard of care and in line with the current local label will be followed for 6 months.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients, 18 to 65 years of age inclusive

• Patients with chronic kidney disease Stage III-IV not on dialysis

• Hb < 10 g/dL (for correction of anemia) or Hb 10-12 g/dL and receiving any other ESA (for maintenance of Hb levels)

• Adequate iron status as judged by the treating physician

Exclusion Criteria:

• Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication

• Significant acute or chronic bleeding

• Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)

• Active malignant disease during the last five years (except non-melanoma skin cancer)

• Uncontrolled or symptomatic secondary hyperparathyroidism

• Epileptic seizure during the last 6 months

• Poorly controlled hypertension (sitting blood pressure > 170/100 mmHG)

• Myocardial infarction or stroke, or severe or unstable CAD

• Severe liver disease during the previous 6 months

• Congestive heart failure NYHA Class III-IV

• Diagnosis or suspicion of pure red cell aplasia (PRCA)

• Planned elective surgery during the study period (except cataract surgery and vascular access surgery)

• Transfusion of red blood cells during the previous 2 months

• Pregnant women

• Any contra-indications to Mircera

Study Design

N/A

Related Conditions & MeSH terms

• Anemia

Intervention

Other:
• Cohort

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche