Liver CirrhosisNCT02047240
Renal Function Determination in Patients With Liver Cirrhosis
An observational study of Liver Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
We have several ways to appropriately determine renal function in healthy patients and in several diseases, in cirrhotic population we dont have a precise tool that has sufficient precision that reflects glomerular function, although it has been reported that cystatin C, because of its nature could improve diagnostic… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 92 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2013to Apr 2016
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients will be selected from the Liver Clinic from the Gastroenterology Department at a tertiary care center in Mexico
Who may be able to join
- Liver cirrhosis
- Stability in creatinine levels in the previous three months (variation <0.3 mg/dL)
- Signed informed consent
Who cannot join
- Pregnancy
- Hepatocellular carcinoma
- Cerebrovascular events
- Decompensated heart failure
- Drugs that modify serum creatinine levels
- Renal replacement therapy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City, Mexico City, 14000
About this study
Official title: Renal Function Determination With Creatinine and Cystatin C Dependent Formulas Compared to Gold Standard DTPA-TC-99 (Diethylene-triamine-pentaacetate- Technetium-99) in Mexican Cirrhotic Patients
We have several ways to appropriately determine renal function in healthy patients and in several diseases, in cirrhotic population we dont have a precise tool that has sufficient precision that reflects glomerular function, although it has been reported that cystatin C, because of its nature could improve diagnostic accuracy to determinate the renal function in this population.
The investigators hypothesize that glomerular filtration obtained from cystatin-C-derived formulas are more accurate when compared to creatinine-derived formulas with DTPA-Tc99 (diethylene-triamine-pentaacetate- technetium-99) as gold standard.
Read the detailed description
The aim of the study is to determine if the formulas for glomerular filtration are close to the estimation of actual renal function in mexican cirrhotic patients of different etiologies.
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, glomerular filtration, cystatin C
- Medical subject headings
- Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of glomerular filtration through several formulas in cirrhotic patients
Determination of glomerular filtration through several formulas dependent of creatinine and cystatin C and the gold standard
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Aldo Torre, MD MSci, Study director, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047240
- Sponsor's protocol ID
- FILT01
- Status last verified
- Jun 2016
- First submitted
- 23 Jan 2014
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Function Determination With Creatinine and Cystatin C Dependent Formulas Compared to Gold Standard DTPA-TC-99 (Diethylene-triamine-pentaacetate- Technetium-99) in Mexican Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT02047240
- Acronym / sponsor ID
- FILT01
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, glomerular filtration, cystatin C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Jan 2014 (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.
We have several ways to appropriately determine renal function in healthy patients and in several diseases, in cirrhotic population we dont have a precise tool that has sufficient precision that reflects glomerular function, although it has been reported that cystatin C, because of its nature could improve diagnostic accuracy to determinate the renal function in this population.
The investigators hypothesize that glomerular filtration obtained from cystatin-C-derived formulas are more accurate when compared to creatinine-derived formulas with DTPA-Tc99 (diethylene-triamine-pentaacetate- technetium-99) as gold standard.
Detailed description
The aim of the study is to determine if the formulas for glomerular filtration are close to the estimation of actual renal function in mexican cirrhotic patients of different etiologies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be selected from the Liver Clinic from the Gastroenterology Department at a tertiary care center in Mexico
Key inclusion criteria (3 listed)
- Liver cirrhosis
- Stability in creatinine levels in the previous three months (variation <0.3 mg/dL)
- Signed informed consent
Key exclusion criteria (6 listed)
- Pregnancy
- Hepatocellular carcinoma
- Cerebrovascular events
- Decompensated heart failure
- Drugs that modify serum creatinine levels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of glomerular filtration through several formulas in cirrhotic patients
Time frame: Baseline
Determination of glomerular filtration through several formulas dependent of creatinine and cystatin C and the gold standard
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 8 Jun 2016.
Related trials for Liver Cirrhosis
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
Enrolling by invitationPhase 4
Low Dose Versus Standard Dose Albumin
Decompensated Cirrhosis and Ascites
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 3
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
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.
Aldo Torre, MD MSci study director
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran 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 3 inclusion and 6 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 8 Jun 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Levels of glomerular filtration through several formulas in cirrhotic patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2016.