NCT00737711

Brief Summary

This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

June 2, 2016

Completed
Last Updated

June 2, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

August 18, 2008

Results QC Date

March 8, 2016

Last Update Submit

April 26, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period

    The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.

    Baseline (Week 0) and Week 16

Secondary Outcomes (27)

  • Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter

    Up to Week 16

  • Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16

    Week 12 to Week 16

  • Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16

    Week 12 to Week 16

  • Number of Participants With Adverse Events, Serious Adverse Events and Deaths

    Up to Week 18

  • Number of Participants With Abnormal Electrocardiogram

    Up to Week 16

  • +22 more secondary outcomes

Study Arms (1)

Mircera

EXPERIMENTAL
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera]DRUG

iv 0.6 micrograms/kg every 2 weeks

Mircera

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male or female patients, \>=18 years of age;
  • chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
  • no prior erythropoietin stimulating agent (ESA) therapy.

You may not qualify if:

  • blood transfusion within the previous 4 weeks;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease;
  • congestive heart failure (NYHA Class IV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Ahmedabad, 380007, India

Location

Unknown Facility

Bangalore, 560034, India

Location

Unknown Facility

Chennai, 603103, India

Location

Unknown Facility

Coimbatore, 641004, India

Location

Unknown Facility

Gujarat, 387 001, India

Location

Unknown Facility

Hyderabad, 500001, India

Location

Unknown Facility

Kerala, 682017, India

Location

Unknown Facility

Kolkata, 700099, India

Location

Unknown Facility

Ludhiana, India

Location

Unknown Facility

Mumbai, 400026, India

Location

Unknown Facility

Mumbai, India

Location

Unknown Facility

New Delhi, 110 060, India

Location

Unknown Facility

New Delhi, 110017, India

Location

Unknown Facility

New Delhi, 110026, India

Location

Unknown Facility

Vellore, 632 004, India

Location

Unknown Facility

Vishakpatnam, 530002, India

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 616878333

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 19, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

June 2, 2016

Results First Posted

June 2, 2016

Record last verified: 2016-04

Locations

IN(16)