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

Amgen

Status and phase: Terminated; Phase 3

Conditions: Chronic Kidney Disease; Anemia

Treatments: Drug: Placebo; Drug: Darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00364845

20050122

Details and patient eligibility

About

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

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups, including a placebo group

Darbepoetin alfa

Active Comparator group

Description:

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.

Treatment:

Drug: Darbepoetin alfa

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo