NCT00907608

Brief Summary

The purpose of this study is to examine the effect of partial correction of anemia with Darbepoetin alfa to a target of 11 g.dL (female) or 12 g/dL (male) on the reduction of cardiovascular morbidity and total mortality.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

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

December 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2009

Completed
Last Updated

May 22, 2009

Status Verified

May 1, 2009

Enrollment Period

1.4 years

First QC Date

May 21, 2009

Last Update Submit

May 21, 2009

Conditions

Diabetes MellitusChronic Kidney DiseaseAnemia

Outcome Measures

Primary Outcomes (2)

  • Composite cardiovascular endpoint of myocardial infarction, congestive heart failure, arrhythmia, stroke, transient ischemic attack, amputation or ulceration / necrosis of lower limb

    3 years

  • Death

    3 years

Secondary Outcomes (6)

  • Doubling of mean serum creatinine

    3 years

  • 50% reduction in mean estimated glomerular filtration rate during baseline period as estimated by the abbreviated Modification of Diet in Renal Disease equation

    3 years

  • Estimated glomerular filtration rate less than 15 mL/min/1.73m-2

    3 years

  • Change in fasting urinary albumin creatinine ratio

    3 years

  • Need for dialysis

    3 years

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Receive Darbepoetin alfa

Drug: Darbepoetin alfa

2

NO INTERVENTION

Interventions

Darbepoetin alfaDRUG

Starting dose of 20 microgram per week, to be titrated over a 3-month period until target hemoglobin level is reached (female: 11 g/dL and male: 12 g/dL). Route of administration is subcutaneous injection.

1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients aged above 20 years old
  • Patients with Type 1 or Type 2 diabetes mellitus
  • Estimated glomerular filtration rate less than 59 mL/min/1.73m2
  • Patients not on renal replacement therapy
  • Hemoglobin level at baseline : women less than 9.5 g/dL (inclusive) and men less than 10.5 g/dL (inclusive)
  • All patients should be on a stable dose of the following medications 4 weeks before enrolment :
  • Aspirin 80mg daily unless contraindicated
  • Statin to achieve stable and optimal LDL-cholesterol level
  • Maximal tolerated dose of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers
  • Anti-hypertensive treatment to maintain blood pressure target of less than 130/80 mmHg or a level achieved without undue side effects
  • Oral anti-diabetic drugs or insulin to maintain HbA1C less than 9.5%

You may not qualify if:

  • Pregnancy, breast feeding or patient has plans of becoming pregnant during the study period
  • Known non-diabetic renal disease
  • Known cause of anemia not related to chronic kidney disease
  • Presence of hemoglobinopathy
  • History of pure red cell aplasia
  • Known allergy to Darbepoetin alfa
  • Severe liver impairment (\>= 3x ULN of ALT)
  • Poorly controlled hypertension, systolic BP \>= 160mmHg or diastolic BP \>= 100mmHg
  • Significant cardiovascular disease within 3 months of enrolment including acute coronary syndrome, cardiac revascularization procedure, transient ischemic attack and cerebrovascular accident
  • History of major gastrointestinal bleeding in the 5 years prior to consent
  • Investigational drugs within 30 days of enrolment
  • Any other medical conditions that is considered as unsuitable for the study by investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Diabetes MellitusRenal Insufficiency, ChronicAnemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Peter CY Tong, MBChB

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 22, 2009

Study Start

December 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 22, 2009

Record last verified: 2009-05

Locations

CN(1)