NCT01271478

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2013

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.3 years

First QC Date

January 3, 2011

Last Update Submit

December 18, 2018

Conditions

InflammationEnd-stage Renal Disease

Keywords

inflammationtelmisartancaptoprilhemodialysis

Outcome Measures

Primary Outcomes (1)

  • Serum concentrations of TNF-a, IL-6 and CRP

    3 months

Study Arms (4)

Telmisartan plus Captopril

EXPERIMENTAL

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

Telmisartan plus Placebo

EXPERIMENTAL

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

Captopril plus Placebo

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

2 tablets of placebo orally twice a day

Drug: Placebo

Interventions

captopril plus placeboDRUG

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

Also known as: Capotena
Captopril plus Placebo
telmisartan plus placeboDRUG

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

Also known as: micardis
Telmisartan plus Placebo
Telmisartan plus CaptoprilDRUG

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)

Also known as: Capotena, Micardis
Telmisartan plus Captopril
PlaceboDRUG

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

Also known as: Starch
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • ≥2 months on hemodialysis
  • Arteriovenous fistula as vascular access
  • Endorsement of informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Especialidades, CMNO, IMSS

Guadalajara, Jalisco, 44320, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 20051840BACKGROUND

MeSH Terms

Conditions

InflammationKidney Failure, Chronic

Interventions

CaptoprilTelmisartanStarch

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

ProlineImino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

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

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Medical Research Unit of Renal Diseases

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 6, 2011

Study Start

August 1, 2009

Primary Completion

December 1, 2010

Study Completion

August 31, 2013

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations

ME(1)