NCT01890577

Brief Summary

An observational study to describe the treatment of anaemia in patients with chronic kidney disease, who are receiving dialysis treatment at selected study centres in South Africa.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
terminated

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

April 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 2, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 13, 2015

Completed
Last Updated

July 12, 2016

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

April 18, 2013

Results QC Date

March 31, 2015

Last Update Submit

June 8, 2016

Conditions

Chronic Kidney Disease, Receiving Dialysis

Keywords

Chronic kidney diseaseDialysisErythropoiesis stimulating agentSouth Africa

Outcome Measures

Primary Outcomes (1)

  • Haemoglobin Concentration

    Due to the premature termination of the study no outcome measure data were analyzed.

    Each 4-week period for the duration of the study period (15 months)

Secondary Outcomes (9)

  • Hemoglobin Excursions

    Over the 15-month observation period

  • Hemoglobin Within the Range 10-12 g/dL Over Time

    On a continuous basis over the 15-month observation period

  • Erythropoiesis Stimulating Agent (ESA) Usage

    Over the 15-month observation period

  • ESA/Aranesp Dose Ratio

    Day of commencement of Aranesp

  • Iron Therapy Use

    Over the 15-month observation period

  • +4 more secondary outcomes

Study Arms (1)

Study population

Single cohort of dialysis patients

Drug: Aranesp

Interventions

AranespDRUG

Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice.

Study population

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients receiving dialyis at South African study centres and having received at least one dose of Aranesp

You may qualify if:

  • Adult patients undergoing chronic haemodialysis or peritoneal dialysis
  • Commenced Aranesp therapy 3-6 months prior to enrolment
  • Erythropoiesis stimulating agent (ESA) naive or treated with another ESA prior to commencing Aranesp
  • Informed consent obtained

You may not qualify if:

  • Received Aranesp in an interventional study within 6 months prior to start of observation period
  • Receive investigational product during the observation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Glenwood, KwaZulu-Natal, 4083, South Africa

Location

Research Site

Umhlanga, KwaZulu-Natal, 4320, South Africa

Location

Research Site

Cape Town, Western Cape, 7800, South Africa

Location

Research Site

Durban, 4001, South Africa

Location

Research Site

Kimberley, 8300, South Africa

Location

Research Site

Lenasia, 1821, South Africa

Location

Research Site

Roodepoort, 1709, South Africa

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2013

First Posted

July 2, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 12, 2016

Results First Posted

April 13, 2015

Record last verified: 2016-06

Locations

ZA(7)