Hyperhomocysteinemia in hemodialysis. MedDRA version: 9.1 Level: SOC Classification code 10038359
Conditions
Interventions
Trade Name: HIDONAC
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Acetylcysteine
Concentration unit: g gram(s)
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Sistemic diseases, such as cancer, lupus, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed