A Study Of Mircera In Patients With Kidney Disease Who Ar... | NCT02490514

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

NCT02490514

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Aug 18, 2015Estimated

Enrollment

153Actual

Phase

Not provided

Conditions

Renal Tubular Acidosis, Distal, With Hemolytic Anemia

Interventions

No intervention

Countries

Serbia

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

Aug 2015

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

Dec 2009

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jul 2, 2015

First Submission Date that Met QC Criteria

Jul 2, 2015

First Posted Date

Jul 3, 2015Estimated

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

Aug 17, 2015

Last Update Posted Date

Aug 18, 2015Estimated

Description Module

Brief Summary

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.

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

153Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention was administered in this study.	Mircera

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment		12 months

Secondary Outcomes

Measure	Description	Time Frame
Hb Levels At Start And End Of Treatment		12 months
Mircera Dose At Start And End Of Treatment		12 months
Time To Achieve Response To Mircera

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Condition Browse Module

MeSH Terms

ID	Term
C566910	Renal Tubular Acidosis, Distal, With Hemolytic Anemia

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Belgrade		11000	Serbia