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

Roche

Status: Completed

Conditions: Renal Tubular Acidosis, Distal, With Hemolytic Anemia

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02490514

ML25065

Details and patient eligibility

About

This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12 months at a dose to be determined by the investigator.

Enrollment: 153 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 </= 75 years of age
• 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

Trial design

153 participants in 1 patient group

Mircera

Description:

Patients with stage III-IV CKD received open-label Mircera for 12 months at a dose to be determined by the investigator.

Treatment:

Other: No intervention