Safety and Efficacy Study of the Effect of Etanercept in Hemodialysis Patients

Kaysen, George A., M.D., Ph.D.

Status and phase: Terminated; Phase 2

Conditions: End Stage Renal Disease

Treatments: Drug: Placebo; Drug: Etanercept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00293202

200311904

Details and patient eligibility

About

Etanercept is a novel anti-inflammatory agent currently used in patients with rheumatoid arthritis. We are examining whether Etanercept is effective in improving the nutritional status of hemodialysis patients as a consequence of its ability to decrease inflammation.

Full description

Hemodialysis patients with end stage renal disease have a high mortality rate. In individual patients, mortality is associated with a low serum albumin concentration, a marker of poor nutritional status, and with elevated C-reactive protein, a marker of inflammation. Since efforts to improve nutrition through dietary intake have not been successful, inflammation is thought to play a key role in determining nutritional status. Recently, it has been shown that malnutrition, inflammation, and atherosclerosis are closely related in patients with chronic renal failure. It is our hypothesis that suppression of the cycle of inflammation, malnutrition, and vascular injury caused by atherosclerosis will improve survival in dialysis patients. This study is designed to examine whether suppression of the inflammatory response can be accomplished safely with Etanercept and to determine if this suppression will improve nutritional status and clinical outcome in hemodialysis patients with poor nutritional status and evidence of inflammation.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of end stage renal disease

Exclusion criteria

• History of Tuberculosis History of Recurrent Infection Recent AMI, Cancer within previous 5 years Presence of Hepatitis B, Hepatitis C, HIV, systemic lupus erythematosis, presence of transcutaneous access (external catheter)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

10 participants in 2 patient groups, including a placebo group

Etanercept 25 mg

Active Comparator group

Description:

Etanercept 25 mg injection twice a week

Treatment:

Drug: Etanercept

Saline

Placebo Comparator group

Description:

Saline injection twice a week

Treatment:

Drug: Placebo