Therapy of hyperhomocysteinemia in hemodialysis patients:effects of acetylcysteine and folates. - ND

Conditions: Hyperhomocysteinemia in hemodialysis.
MedDRA version: 9.1Level: SOCClassification code 10038359

Registration Number: EUCTR2007-000451-34-IT

Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Chronic uremic patients undergoing hemodialysis therapy will be recruited among Chronic Hemodialysis Centers. Clinically stable patients will be selected, undergoing hemodialysis since more than three months, provided that they will not be affected by systemic diseases such as cancer, lupus erythematosus, etc. Patients, if receiving folate therapy, will undergo a washout period of two months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Sistemic diseases, such as cancer, lupus, etc.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We propose to evaluate the efficacy, in terms of its homocysteine-lowering effect, of ev acetylcysteine in a group of folate-replete hemodialysis patients. Acetylcysteine will be administered during the course of the dialysis session, for ten consecutive dialyses. Homocysteine levels will be measured at the beginning of the study, at the end, and after two months after study end.;Secondary Objective: Safety and tollerability of the drug.;Primary end point(s): Reduction in plasma homocysteine levels.

Secondary Outcome Measures