NCT02569515

Brief Summary

This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

4 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

October 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

October 5, 2015

Last Update Submit

November 1, 2016

Conditions

Anemia

Outcome Measures

Primary Outcomes (4)

  • Percentage of participantss who change to once weekly NeoRocormon

    10 months

  • Percentage of participants with local intolerabilities (pain/allergic reactions)

    10 months

  • Percentage of participants who withdrew due to inability to use RecoPen

    10 months

  • Percentage of participants who changed dose during treatmnent

    10 months

Secondary Outcomes (1)

  • Quality of life evaluated by the Short Form 36

    10 months

Study Arms (1)

Epoetin Beta

EXPERIMENTAL

Patients will be administered 3 times (X) 30 International unis per kilogram(IU/Kg body weight per week of eopetin beta subcurtaneously using the device RecoPen. The dosage could be increased every 4 weeks by 3 X20 IU/Kg.

Drug: Epoetin Beta

Interventions

Epoetin BetaDRUG

Initial dose: 3X30 IU/Kg body weight administered subcutaneously using RecoPen. Dosage could be increased by 3X20 IU/Kg every 4 weeks up to a maximum of 720 IU/Kg per week.

Also known as: NeoRecormon
Epoetin Beta

Eligibility Criteria

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

You may qualify if:

  • Adult patients 18-65 years of age
  • Chronic renal failure (Stages I-III)
  • No previous epoetin therapy

You may not qualify if:

  • Poorly controlled hypertension
  • History or evidence of malignancy
  • Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug
  • Women who are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Sofia, 1233, Bulgaria

Location

Unknown Facility

Sofia, 1431, Bulgaria

Location

Unknown Facility

Sofia, 1504, Bulgaria

Location

Unknown Facility

Varna, 9002, Bulgaria

Location

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 6, 2015

Study Start

October 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

BU(4)