Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

Phase 4

Completed

• Conditions: Inflammation; End-stage Renal Disease
• Interventions: Drug: Telmisartan plus Captopril; Drug: captopril plus placebo; Drug: Placebo; Drug: telmisartan plus placebo

• Registration Number: NCT01271478
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief 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.

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-12
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-05
• Study First Posted: 2011-01-06
• Study Completion: 2013-08-31
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥18 years
• ≥2 months on hemodialysis
• Arteriovenous fistula as vascular access
• Endorsement of informed consent

Exclusion Criteria

• Inflammatory cause of ESRD
• Liver disease, cancer, AIDS
• Any infectious disease 2 months before the study
• Failed kidney graft
• Hypersensitivity to angiotensin converting enzyme inhibitors or angiotensin receptor blockers
• Arterial hypotension
• Pregnancy
• Treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins, ACE inhibitors or ARB 3 months previous to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan plus Captopril	Telmisartan plus Captopril	captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day)
Captopril plus Placebo	captopril plus placebo	patients received captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day
Placebo	Placebo	2 tablets of placebo orally twice a day
Telmisartan plus Placebo	telmisartan plus placebo	telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day) plus 1 tablet of placebo orally twice a day

Primary Outcome Measures

Name	Time	Method
Serum concentrations of TNF-a, IL-6 and CRP	3 months

Trial Locations

Locations (1)

Hospital de Especialidades, CMNO, IMSS; 🇲🇽 Guadalajara, Jalisco, Mexico