InflammationPhase 4NCT01271478
Use of Telmisartan and Captopril in Inflammation of Hemodialysis Patients
A Phase 4 study testing Telmisartan plus Captopril in people with Inflammation and End-stage Renal Disease, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammation, End-stage Renal Disease
- What is being tested?
- Telmisartan plus Captopril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2009to 31 Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- ≥2 months on hemodialysis
- Arteriovenous fistula as vascular access
- Endorsement of informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital de Especialidades, CMNO, IMSS
Guadalajara, Jalisco, 44320
About this study
Official title: Effect of Telmisartan and Captopril on Systemic Inflammation of Patients on Hemodialysis
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).
Read the 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.
- Conditions
- Inflammation, End-stage Renal Disease
- Being tested
- captopril plus placebo, telmisartan plus placebo, Telmisartan plus Captopril, Placebo
- Keywords
- inflammation, telmisartan, captopril, hemodialysis
- Medical subject headings
- Inflammation, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
captopril plus placeboDrug
Also called Capotena
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 placeboDrug
Also called micardis
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 CaptoprilDrug
Also called Capotena, Micardis
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)
PlaceboDrug
Also called Starch
Patients in this group will receive 2 tablets of placebo (starch) twice a day.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: 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 Receives: Drug: captopril plus placebo |
| Placebo | Placebo comparator | 2 tablets of placebo orally twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations of TNF-a, IL-6 and CRP
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completion31 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alfonso Martín Cueto Manzano, Coordinación de Investigación en Salud, Mexico
- Investigators
- Alfonso M. M Cueto-Manzano, MD, MSc, PhD, Study chair, Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271478
- Sponsor's protocol ID
- FIS/IMSS/PROT/G09/739
- Other IDs
- Registry CLIS
- Status last verified
- Dec 2018
- First submitted
- 3 Jan 2011
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20051840
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telmisartan and Captopril on Systemic Inflammation of Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT01271478
- Acronym / sponsor ID
- FIS/IMSS/PROT/G09/739
- Conditions
- Inflammation, End-stage Renal Disease
- Keywords
- inflammation, telmisartan, captopril, hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- 31 Aug 2013 (actual)
- First posted
- 6 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telmisartan plus Captopril | Experimental | Drug: Telmisartan plus Captoprilcaptopril 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 plus Placebo | Experimental | Drug: telmisartan plus placebotelmisartan 80 mg/day (1 tablet of 40 mg orally twice a day) plus 1 tablet of placebo orally twice a day |
| Captopril plus Placebo | Experimental | Drug: captopril plus placebopatients received captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day |
| Placebo | Placebo comparator | Drug: Placebo2 tablets of placebo orally twice a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- ≥2 months on hemodialysis
- Arteriovenous fistula as vascular access
- Endorsement of informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| captopril plus placeboAlso: CapotenaThis 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 | Drug | Captopril plus Placebo |
| telmisartan plus placeboAlso: micardisPatients 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 | Drug | Telmisartan plus Placebo |
| Telmisartan plus CaptoprilAlso: Capotena, MicardisPatients 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) | Drug | Telmisartan plus Captopril |
| PlaceboAlso: StarchPatients in this group will receive 2 tablets of placebo (starch) twice a day. | Drug | Placebo |
Primary outcome
Serum concentrations of TNF-a, IL-6 and CRP
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 20051840Ordaz-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfonso M. M Cueto-Manzano, MD, MSc, PhD study chair
Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telmisartan plus Captopril in people with Inflammation and End-stage Renal Disease, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentrations of TNF-a, IL-6 and CRP (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01271478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.