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CompletedNCT01667380Updated Nov 2, 2016

An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)

An observational study in Anemia, sponsored by Hoffmann-La Roche. Completed at 1 site in Montenegro. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
78
Ages
18 Years and older
Sex
All
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Study summary

This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.

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Conditions studied

  • Anemia

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03

In context

Anemia

1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.

This study's enrollment of 78 is below the median of 270 across 368 observational studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are, in the opinion of the treating physician, not expected at baseline to require dialysis within 12 months
  • Patients with chronic renal anemia with stage V CKD on dialysis
  • No to ESA treatment

Exclusion criteria

Exclusion Criteria:

  • Uncontrolled hypertension
  • to the active substance or any other of the of Mircera and other ESAs
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
78 participants (actual)

Groups and cohorts

  • Cohort
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What researchers measure

Primary outcomes

  1. Dosage/schedule of Mircera treatment in clinical practice

    Time frame: approximately 3 years

Secondary outcomes

  1. Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment

    Time frame: approximately 3 years

  2. Change in Hb levels

    Time frame: from baseline to Month 12

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Study locations

1 site
  • Podgorica, 81 000, Montenegro
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01667380
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Aug 17, 2012
Start date
Apr 2012
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Nov 2, 2016

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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