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OpenTrials
Completed

NCT Number: NCT02490514

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

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.

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Key information

Conditions

Renal Tubular Acidosis, Distal, With Hemolytic Anemia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Belgrade, Serbia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention was administered in this study.

Primary outcomes

  1. Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment

    Time frame: 12 months

Secondary outcomes

  1. Hb Levels At Start And End Of Treatment

    Time frame: 12 months

  2. Mircera Dose At Start And End Of Treatment

    Time frame: 12 months

  3. Time To Achieve Response To Mircera

    Time frame: 12 months

  4. Percent Of Participants Treated With Iron Supplements

    Time frame: 12 months

  5. Percent of Participants Who Required Transfusion At Start And End Of Treatment

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 3, 2015
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.