Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01271478

Enrollment

Registered

2011-01-06

Start date

2009-08-31

Completion date

2013-08-31

Last updated

2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Renal Disease, Inflammation

Keywords

inflammation, telmisartan, captopril, hemodialysis

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.

Interventions

DRUGcaptopril 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

DRUGtelmisartan 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

DRUGTelmisartan 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)

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Serum concentrations of TNF-a, IL-6 and CRP	3 months

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026