NCT01271478

Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

Effect of Telmisartan and Captopril on Systemic Inflammation of Patients on Hemodialysis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to compare the dual use of telmisartan and captopril vs the individual use of such drugs and placebo on the systemic inflammation of patients on hemodialysis (HD).

Detailed description

Once included, patients will be randomly allocated (by a computer-generated randomization list) to one of the following groups: group 1 will receive Captopril, group 2 Telmisartan, group 3 Captopril plus Telmisartan, and group 4 Placebo. Drugs will be provided as tablets during a period of 3 months. All patients will have 3 HD sessions per week, with the same kind of single-use dialysis membrane and dialysate Monthly visits will be scheduled for clinical and biochemical evaluations. A blood sample will be taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). In serum samples at 0, 1 and 3 months, tumor necrosis factor alpha (TNF-α) and interleukin 6 (IL-6) concentrations will be measured by ELISA using high sensitivity kits. Additionally, in the same serum samples, C-reactive protein (CRP) concentrations will be measured by nephelometry using high sensitivity kits. All laboratory measurements, including inflammation markers, will be performed in the Central Laboratory (Hospital de Especialidades, Centro Médico Nacional de Occidente), by the same personnel blinded to patient's details. Treatment compliance will be recorded by counting tablets left in the container at the end of each monthly visit.

Conditions

• Inflammation
• End-stage Renal Disease

Interventions

Type	Name	Description
DRUG	captopril plus placebo	This group will receive captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day
DRUG	telmisartan plus placebo	Patients of this group will receive telmisartan 80 mg/day (1 tablet 40 mg orally twice a day) plus 1 tablet of placebo twice a day
DRUG	Telmisartan plus Captopril	Patients of this group will receive captopril 50 mg/day (1 tablet 25 mg orally twice a day) plus telmisartan 80 mg/day (1 tablet 40 mg orally twice a day)
DRUG	Placebo	Patients in this group will receive 2 tablets of placebo (starch) twice a day.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-12-01
• Completion: 2013-08-31
• First posted: 2011-01-06
• Last updated: 2018-12-19

Locations

1 site across 1 country: Mexico