Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alfonso Martín Cueto Manzano, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01271478
First received: January 3, 2011
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Inflammation
End-stage Renal Disease
Drug: captopril plus placebo
Drug: telmisartan plus placebo
Drug: Telmisartan plus Captopril
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Telmisartan and Captopril on Systemic Inflammation of Patients on Hemodialysis

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Serum concentrations of TNF-a, IL-6 and CRP [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: August 2009
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telmisartan plus Captopril
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)
Drug: 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)
Other Names:
  • Capotena
  • Micardis
Experimental: Telmisartan plus Placebo
telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day) plus 1 tablet of placebo orally twice a day
Drug: 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
Other Name: micardis
Experimental: Captopril plus Placebo
patients received captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day
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
Other Name: Capotena
Placebo Comparator: Placebo
2 tablets of placebo orally twice a day
Drug: Placebo
Patients in this group will receive 2 tablets of placebo (starch) twice a day.
Other Name: Starch

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271478

Locations
Mexico
Hospital de Especialidades, CMNO, IMSS
Guadalajara, Jalisco, Mexico, 44320
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Study Chair: Alfonso M. M Cueto-Manzano, MD, MSc, PhD Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
  More Information

Publications:
Responsible Party: Alfonso Martín Cueto Manzano, Head, Medical Research Unit of Renal Diseases, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01271478     History of Changes
Other Study ID Numbers: FIS/IMSS/PROT/G09/739, Registry CLIS
Study First Received: January 3, 2011
Last Updated: February 12, 2013
Health Authority: Mexico: Coordinación de Investigación en Salud

Keywords provided by Coordinación de Investigación en Salud, Mexico:
inflammation
telmisartan
captopril
hemodialysis

Additional relevant MeSH terms:
Inflammation
Kidney Diseases
Kidney Failure, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Telmisartan
Captopril
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014