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Completed

NCT Number: NCT01271478

Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

captopril plus placebo

Drug

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

Other names: Capotena

telmisartan plus placebo

Drug

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

Other names: micardis

Telmisartan plus Captopril

Drug

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)

Other names: Capotena, Micardis

Placebo

Drug

Patients in this group will receive 2 tablets of placebo (starch) twice a day.

Other names: Starch

Primary outcomes

  1. Serum concentrations of TNF-a, IL-6 and CRP

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
Jan 6, 2011
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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