STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-02-28

Brief Summary

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Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks

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Detailed Description

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This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD patients for 36 weeks.

Conditions

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Anemia Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Darbepoetin alfa

Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.

Group Type ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type DRUG

Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion.

Placebo

Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Prefilled syringe placebo, to match active arm

Interventions

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Darbepoetin alfa

Starting dose was calculated at 0.75 micrograms per kilogram (μg/kg) body weight at randomization, rounded to nearest prefilled syringe dose unit. Dose was titrated incrementally. Monthly dose was initially double the every 2 week dose at time of conversion.

Intervention Type DRUG

Placebo

Prefilled syringe placebo, to match active arm

Intervention Type DRUG

Other Intervention Names

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Aranesp®

Eligibility Criteria

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Inclusion Criteria

* Stage 3-5 CKD not on dialysis
* Patients ≥ 70 years of age
* Haemoglobin \< 110g/L at screening
* Transferrin saturation ≥ 15% at screening

Exclusion Criteria

* Clinical history of type 2 diabetes mellitus
* Anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant
* Uncontrolled hypertension on two separate measurements during screening
* Use of any erythropoietic protein within 12 weeks of screening

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No