An Observational Study of Mircera (Methoxy Polyethylene G... | NCT01213485

Studies
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease on Dialysis (HORTENSIA)

NCT01213485

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

419Actual

Phase

Not provided

Conditions

Anemia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Sep 28, 2010

First Submission Date that Met QC Criteria

Oct 1, 2010

First Posted Date

Oct 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This observational study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient for 12 months.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

419Actual

Label	Type	Description	Intervention Names
Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Haemoglobin levels		Month 6
Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice		Month 6

Secondary Outcomes

Measure	Description	Time Frame
Change in haemoglobin/haematocrit		from baseline to Month 12
Biological parameters of anemia: transferrin saturation, serum ferritin, folates		12 months
Efficacy of dialysis (Kt/V, urea levels)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients, >/= 18 years of age
Chronic kidney disease, on dialysis for > 3 months
Treatment-naïve or previous treatment with ESA
Initiation of treatment with Mircera for renal insufficiency associated anemia by decision of the treating physician

Exclusion Criteria:

Participation in a clinical trial
Anemia due to an associated malignant pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic kidney disease on dialysis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Neuilly-sur-Seine		92521	France

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided