Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients
Primary Purpose
Inflammation, End-stage Renal Disease
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
captopril plus placebo
telmisartan plus placebo
Telmisartan plus Captopril
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring inflammation, telmisartan, captopril, hemodialysis
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
Sites / Locations
- Hospital de Especialidades, CMNO, IMSS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Telmisartan plus Captopril
Telmisartan plus Placebo
Captopril plus Placebo
Placebo
Arm 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)
telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day) plus 1 tablet of placebo orally twice a day
patients received captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day
2 tablets of placebo orally twice a day
Outcomes
Primary Outcome Measures
Serum concentrations of TNF-a, IL-6 and CRP
Secondary Outcome Measures
Full Information
NCT ID
NCT01271478
First Posted
January 3, 2011
Last Updated
December 18, 2018
Sponsor
Coordinación de Investigación en Salud, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT01271478
Brief Title
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
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
August 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, End-stage Renal Disease
Keywords
inflammation, telmisartan, captopril, hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telmisartan plus Captopril
Arm Type
Experimental
Arm 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)
Arm Title
Telmisartan plus Placebo
Arm Type
Experimental
Arm Description
telmisartan 80 mg/day (1 tablet of 40 mg orally twice a day) plus 1 tablet of placebo orally twice a day
Arm Title
Captopril plus Placebo
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 tablets of placebo orally twice a day
Intervention Type
Drug
Intervention Name(s)
captopril plus placebo
Other Intervention Name(s)
Capotena
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
telmisartan plus placebo
Other Intervention Name(s)
micardis
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Telmisartan plus Captopril
Other Intervention Name(s)
Capotena, Micardis
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Starch
Intervention Description
Patients in this group will receive 2 tablets of placebo (starch) twice a day.
Primary Outcome Measure Information:
Title
Serum concentrations of TNF-a, IL-6 and CRP
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfonso M. M Cueto-Manzano, MD, MSc, PhD
Organizational Affiliation
Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Especialidades, CMNO, IMSS
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44320
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
20051840
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.
Results Reference
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Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients
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