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Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients

NCT ID: NCT01271478

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Inflammation End-stage Renal Disease

Keywords

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inflammation telmisartan captopril hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Telmisartan plus Captopril

Intervention Type DRUG

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)

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

Group Type EXPERIMENTAL

telmisartan plus placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

captopril plus placebo

Intervention Type DRUG

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

Placebo

2 tablets of placebo orally twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients in this group will receive 2 tablets of placebo (starch) twice a day.

Interventions

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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

Intervention Type 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

Intervention Type 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)

Intervention Type DRUG

Placebo

Patients in this group will receive 2 tablets of placebo (starch) twice a day.

Intervention Type DRUG

Other Intervention Names

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Capotena micardis Capotena Micardis Starch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alfonso Martín Cueto Manzano

Head, Medical Research Unit of Renal Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alfonso M. M Cueto-Manzano, MD, MSc, PhD

Role: STUDY_CHAIR

Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS

Locations

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Hospital de Especialidades, CMNO, IMSS

Guadalajara, Jalisco, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 20051840 (View on PubMed)

Other Identifiers

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Registry CLIS

Identifier Type: REGISTRY

Identifier Source: secondary_id

FIS/IMSS/PROT/G09/739

Identifier Type: -

Identifier Source: org_study_id