A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis

• Register: ClinicalTrials.gov
• Last refreshed on: 31 August 2015
• Main ID: NCT02490514
• Date of registration: 02/07/2015
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis
• Scientific title: Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study
• Date of first enrolment: December 2009
• Target sample size: 153
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02490514
• Study type: Observational
• Study design: Observational Model: Cohort
• Phase: N/A

Countries of recruitment

Serbia

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with stage II-IV CKD not on dialysis, including renal transplant patients,
who are receiving erythropoiesis-stimulating agent (ESA) treatment or are ESA-naive

- Patients who will not require dialysis within 12 months after the start of Mircera
therapy

- Patients whose life expectancy is greater than 12 months after Mircera initiation

- Patients >/= 18 years and
- Patients who are female and of childbearing potential must be using effective
contraception methods

- Patients with no contra-indications to ESA treatment (for example, hypersensitivity,
non-controlled hypertension and others according to the local SmPC)

- Patients who have given written informed consent where local regulations allow or
require it

Exclusion Criteria:

- Patients with stage I-II or stage V CKD

- Poorly controlled hypertension

- Active malignant disease



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Tubular Acidosis, Distal, With Hemolytic Anemia

Intervention(s)

Other: No intervention

Primary Outcome(s)

Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment [Time Frame: 12 months]

Secondary Outcome(s)

Percent of Participants Who Required Transfusion At Start And End Of Treatment [Time Frame: 12 months]

Hb Levels At Start And End Of Treatment [Time Frame: 12 months]

Percent Of Participants Treated With Iron Supplements [Time Frame: 12 months]

Mircera Dose At Start And End Of Treatment [Time Frame: 12 months]

Time To Achieve Response To Mircera [Time Frame: 12 months]

Secondary ID(s)

ML25065

Source(s) of Monetary Support

Please refer to primary and secondary sponsors