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Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease (Hercules)

L

Leiden University Medical Center (LUMC)

Status and phase

Withdrawn
Phase 3
Phase 2

Conditions

Chronic Kidney Disease
Inflammation

Treatments

Drug: rosiglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT00169923
P06.108

Details and patient eligibility

About

The purpose of this study in patients with stage 4 and 5 chronic kidney disease is to determine whether rosiglitazone can reduce inflammatory markers and to investigate its effect on intima media thickness, calcification and pulse wave velocity.

Full description

This is a double-blind randomised placebo-controlled clinical multicenter trial in patients with stage 4 and 5 chronic kidney disease. Eligible patients in the outpatient kidney clinic and patients at the dialysis department will be informed by their treating physician about the study and they will be asked to join the study. Following informed consent the eligible patients will undergo baseline evaluation and will then be followed for a period of 48 weeks. Patients will be randomly divided in two groups: one group will take rosiglitazone (4 mg during the first 8 weeks once daily and 8 mg during the next 40 weeks once daily) and the other group will get placebo. The original medication will be continued. The total follow-up will be 48 weeks.

At the start of the study and at 4, 8, 12, 18, 24 and 48 weeks during follow-up inflammatory parameters (CRP, hs CRP, fetuin, fibrinogen), lipid profile,iron status, glucose and insulin will be measured. Intima media thickness, pulse wave velocity, bone densitometry,subjective global assessment will be performed at 0, 24 and 48 weeks.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Written consent
  • Over 18 years of age
  • Stage 4 or 5 chronic kidney disease according the K/DOQI guidelines

Exclusion criteria

  • Life span of less than one year
  • Alcohol abuse
  • Transaminases > 2.5 times the upper limit
  • Diabetes mellitus
  • Pregnancy
  • Cardiac disease with marked limitation of functional capacity (NYHA III or IV)
  • Use of immunosuppressant agents

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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