Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammation, End-stage Renal Disease

Intervention / Treatment
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* Drug: captopril plus placebo
* Drug: telmisartan plus placebo
* Drug: Telmisartan plus Captopril
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan plus Captopril<br>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) | Drug: Telmisartan plus Captopril<br>* 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)<br>* Other names: Micardis;|
| Experimental: Telmisartan plus Placebo<br>telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day) plus 1 tablet of placebo orally twice a day | Drug: telmisartan plus placebo<br>* 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<br>* Other names: micardis;|
| Experimental: Captopril plus Placebo<br>patients received captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day | Drug: captopril plus placebo<br>* 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<br>* Other names: Capotena;|
| Placebo Comparator: Placebo<br>2 tablets of placebo orally twice a day | Drug: Placebo<br>* Patients in this group will receive 2 tablets of placebo (starch) twice a day.<br>* Other names: Starch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of TNF-a, IL-6 and CRP |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation, telmisartan, captopril, hemodialysis