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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02490514
First received: July 2, 2015
Last updated: NA
Last verified: July 2015
History: No changes posted
  Purpose

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.


Condition Intervention
Renal Tubular Acidosis, Distal, With Hemolytic Anemia
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hemoglobin (Hb) Levels At Start And End Of Treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mircera Dose At Start And End Of Treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Time To Achieve Response To Mircera [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent Of Participants Treated With Iron Supplements [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percent of Participants Who Required Transfusion At Start And End Of Treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: December 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mircera
Patients with stage III-IV CKD received open-label Mircera for 12 months at a dose to be determined by the investigator.
Other: No intervention
No intervention was administered in this study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients 18 to 75 years old with stage III-IV chronic kidney disease not on dialysis

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 </= 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02490514

Locations
Serbia
Belgrade, Serbia, 11000
Cuprija, Serbia, 35230
Kragujevac, Serbia, 34000
NIS, Serbia, 18000
Pirot, Serbia, 18300
Pozarevac, Serbia, 12000
Sabac, Serbia, 15000
Sremska Mitrovica, Serbia, 22000
Uzice, Serbia, 31000
Zrenjanin, Serbia, 23000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02490514     History of Changes
Other Study ID Numbers: ML25065
Study First Received: July 2, 2015
Last Updated: July 2, 2015
Health Authority: Serbia:Medicines and medical devices agency of Serbia

Additional relevant MeSH terms:
Acidosis, Renal Tubular
Anemia, Hemolytic
Acid-Base Imbalance
Acidosis
Anemia
Genetic Diseases, Inborn
Hematologic Diseases
Kidney Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Renal Tubular Transport, Inborn Errors
Urologic Diseases

ClinicalTrials.gov processed this record on July 05, 2015