Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 4

Conditions: Inflammation; End-stage Renal Disease

Treatments: Drug: Placebo; Drug: captopril plus placebo; Drug: Telmisartan plus Captopril; Drug: telmisartan plus placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01271478

FIS/IMSS/PROT/G09/739

Registry CLIS (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Telmisartan plus Captopril

Experimental group

Description:

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)

Treatment:

Drug: Telmisartan plus Captopril

Telmisartan plus Placebo

Experimental group

Description:

telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day) plus 1 tablet of placebo orally twice a day

Treatment:

Drug: telmisartan plus placebo

Captopril plus Placebo

Experimental group

Description:

patients received captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day

Treatment:

Drug: captopril plus placebo

Placebo

Placebo Comparator group

Description:

2 tablets of placebo orally twice a day

Treatment:

Drug: Placebo