Clinical trial NCT01271478: Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients
Official title: Effect of Telmisartan and Captopril on Systemic Inflammation of Patients on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammation
End-stage Renal Disease
Keywords: inflammation
telmisartan
captopril
hemodialysis
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
First posted: 2011-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum concentrations of TNF-a, IL-6 and CRP
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital de Especialidades, CMNO, IMSS
state: Jalisco
Study officials:
affiliation: Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
name: Alfonso M. M Cueto-Manzano, MD, MSc, PhD
role: STUDY_CHAIR
References:
citation: Ordaz-Medina SM, Gonzalez-Plascencia J, Martin del Campo F, Rojas-Campos E, Montanez-Fernandez JL, Espinoza-Gomez F, Cueto-Manzano AM. Is systemic inflammation of hemodialysis patients improved with the use of enalapril? Results of a randomized, double-blinded, placebo-controlled clinical trial. ASAIO J. 2010 Jan-Feb;56(1):37-41. doi: 10.1097/MAT.0b013e3181c1d830.