Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271478
• Other study ID #: FIS/IMSS/PROT/G09/739
• Secondary ID: Registry CLIS
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: August 31, 2013

Study information

• Verified date: December 2018
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2013
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Inflammation
• Kidney Failure, Chronic

Intervention

Drug:
• captopril 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
• telmisartan 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
• Telmisartan 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)
• Placebo
Patients in this group will receive 2 tablets of placebo (starch) twice a day.

Locations

Country	Name	City	State
Mexico	Hospital de Especialidades, CMNO, IMSS	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Ordaz-Medina SM, González-Plascencia J, Martín del Campo F, Rojas-Campos E, Montañez-Fernández JL, Espinoza-Gómez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentrations of TNF-a, IL-6 and CRP		3 months