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A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy

Primary Purpose

Diabetes Mellitus, Chronic Kidney Disease, Anemia

Status

Terminated

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Darbepoetin alfa

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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%

Exclusion Criteria:

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

Sites / Locations

Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

Receive Darbepoetin alfa

Outcomes

Primary Outcome Measures

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

Death

Secondary Outcome Measures

Doubling of mean serum creatinine

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

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

Change in fasting urinary albumin creatinine ratio

Need for dialysis

Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department

Full Information

NCT ID

NCT00907608

First Posted

May 21, 2009

Last Updated

May 21, 2009

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT00907608

Brief Title

A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy

Official Title

A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Terminated

Why Stopped

Due to difficulty in patient recruitment

Study Start Date

December 2007 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Diabetes is the leading cause of end stage renal disease and cardiovascular disease with 60 percent of the global diabetic population coming from Asia. Growing evidence confirms the predictive role of chronic kidney disease (CKD) on cardiovascular morbidity and mortality. This is due to the constellation of conventional and non-conventional risk factors in patients who develop CKD, such as anemia, inflammation and abnormal bone metabolism. In this regard, anemia is a risk factor for cardiovascular disease and all-cause mortality in patients with CKD, patients with left ventricular dysfunction and in general population. Effective erythropoiesis is dependent on the production of erythropoietin by the kidneys. Anemia is a common finding in patients with diabetes and up to 20% of diabetic patients are noted to have anemia. In a meta-analysis of community-based population studies, anemia interacts with CKD to increase the risk of coronary heart disease, stroke and all-cause mortality among patients with diabetes. Previous studies that examined the effect of erythropoietin therapy on anemic subjects with CKD did not find statistical difference in mortality rates between the treated and untreated groups. Possible explanations for the lack of benefits include higher level of blood pressure and increased blood viscosity leading to worsening of chronic congestive heart failure in the treated subjects. We hypothesize that partial correction of hemoglobin may be more appropriate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Chronic Kidney Disease, Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Receive Darbepoetin alfa

Arm Title

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Darbepoetin alfa

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

3 years

Title

Death

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Doubling of mean serum creatinine

Time Frame

3 years

Title

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

Time Frame

3 years

Title

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

Time Frame

3 years

Title

Change in fasting urinary albumin creatinine ratio

Time Frame

3 years

Title

Need for dialysis

Time Frame

3 years

Title

Number of hospital admissions, total number of days of hospital stay and attendance at the Accident and Emergency Department

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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% Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter CY Tong, MBChB

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Prince of Wales Hospital

City

Hong Kong

Country

China

12. IPD Sharing Statement

Learn more about this trial

A Proof-of-Concept Study of Darbepoetin Alfa in Partial Correction of Anemia in Chinese With Diabetic Nephropathy

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