Renal Tubular Acidosis, Distal, With Hemolytic Anemia Clinical Trial
Official title:
Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study
| Verified date | August 2015 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Serbia:Medicines and medical devices agency of Serbia |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 153 |
| Est. completion date | February 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Observational Model: Cohort
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Serbia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment | 12 months | No | |
| Secondary | Hb Levels At Start And End Of Treatment | 12 months | No | |
| Secondary | Mircera Dose At Start And End Of Treatment | 12 months | No | |
| Secondary | Time To Achieve Response To Mircera | 12 months | No | |
| Secondary | Percent Of Participants Treated With Iron Supplements | 12 months | No | |
| Secondary | Percent of Participants Who Required Transfusion At Start And End Of Treatment | 12 months | No |