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Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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