Cirrhosis RenalPhase 4DFG HEPNCT03769597
Description of the Evolution of Plasma and Urinary Concentrations of Iohexol in a Cirrhotic Patient Population
A Phase 4 study testing Iohexol Inj 300 MG/ML in people with Cirrhosis Renal, run by University Hospital, Limoges at 1 site in France.
Trial summary
Background: It is important to accurately assess the glomerular filtration rate (GFR) of patients with liver diseases, particularly cirrhosis, to deliver care and adjust the drugs' posology. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis Renal
- What is being tested?
- Iohexol Inj 300 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2019to 28 Aug 2019
- 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
- Patients with advanced liver disease, with potential indication for liver transplantation, with or without ascites :
- No ascites: 3 patients.
- Grade 1 (mild): ascites only detectable by ultrasound examination. 3 patients.
- Grade 2 (moderate) and Grade 3 (wide): clinically significant ascites, causing moderate symmetrical distension of the abdomen, or causing severe abdominal distension. 3 patients.
- Patients will be over 18 years, affiliated to a social security scheme and give their informed consent.
Who cannot join
- Hypersensitivity to the active substance to the products of iodinated contrasts or to any of the excipients mentioned in Composition section
- History of major or cutaneous immediate reaction delayed injection of iodinated contrast medium (Omnipaque)
- Patients with thyrotoxicosis
- Asthmatic patients
- Patient with a history of dysthyroidism
- Patients with severe cardiovascular disease
Show all 15Show fewer
- Patients with central nervous system disorders especially vascular
- Patients with pheochromocytoma
- Patients with myasthenia
- Patients with sickle cell disease
- Patients with autoimmune disease
- Patients treated with metformin
- Patients requiring anesthesia on the first day of levies
- Patients with an injection of iodine contrast during hospitalization and in both previous weeks. Gadolinium injections are not not contraindicated
- Patients under guardianship or curatorship or incapacitated give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description of the Evolution of Plasma and Urinary Concentrations of Iohexol in a Cirrhotic Patient Population: "Pilot Study on 9 Patients"
Background: It is important to accurately assess the glomerular filtration rate (GFR) of patients with liver diseases, particularly cirrhosis, to deliver care and adjust the drugs' posology.
Purpose: The frequency of chronic renal failure is underestimated in patients with advanced liver disease and the difficulty to assess kidney failure justifies the investigator's study, which aims to describe, by means of a population pharmacokinetic model, the evolution of plasma and urinary concentrations of iohexol, an effective non-ionic, water-soluble contrast agent which is used in radiographic procedures, in cirrhotic patients.
Read the detailed description
Cirrhosis is often complicated by kidney failure and the prognostic value of renal function (serum creatinine) during cirrhosis is included in the MELD model. In addition, chronic kidney disease (15%) after liver transplantation is also an independent mortality factor.
The most commonly used methods to estimate GFR are based on creatinine, but in patients suffering from advanced hepatic disease, such as cirrhosis, this parameter is incorrect, due to the low creatinine production and potentially to elevated serum bilirubin and decreased albumin levels. Furthermore, ascites can interfere with serum creatinine concentration. In this condition, all creatinine-based evaluations of GFR overestimate gold standard-measured GFR. Specific eGFR equations for liver disease or new approaches for estimating GFR may be necessary.
The plasma clearance of iohexol is a recognized technique for the measurement of the glomerular filtration rate (GFR).
- Conditions
- Cirrhosis Renal
- Being tested
- Iohexol Inj 300 MG/ML
- Keywords
- Cirrhosis Renal, GFR, renal function, Bayesian model, plasma clearance, iohexol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iohexol Inj 300 MG/MLDrug
After injecting a loading dose of 5ml of iohexol bolus, blood samples will be taken at given times for 24 hours. The urinary samples will be taken at each urination, with measurement of the exact volume and times
| Study group | Role | What they receive |
|---|---|---|
| Iohexol administration | Experimental | After injecting a loading dose of 5ml of Iohexol Inj 300 MG/ML bolus, blood samples will be taken at given times for 24 hours. The urinary samples will be taken at each urination, with measurement of the exact volume and times Receives: Drug: Iohexol Inj 300 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of plasma concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.
Plasma concentration curves for iohexol according to the time.
Measured: 0 minute, 15 minute, 30 minute, 1 hour, 90 minute, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Change of urinary concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.
Urine concentration curves for iohexol according to the time.
Measured: 0 minute, 4 hours, 8 hours, 12 hours, 24 hours
Secondary outcomes (5)
Calculate the renal clearance of iohexol.
Renal clearance of iohexol obtained by noncompartmental analysis.
Measured: 0 minute, 15 minute, 30 minute, 1 hour, 90 minute, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Calculate the plasma clearance of iohexol.
Urinary clearance of iohexol obtained by noncompartmental analysis.
Measured: 0 minute, 15 minutes, 30 minutes, 1 hour, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Develop a pharmacokinetic model for the estimation of renal clearance from plasma clearance.
The evaluation of the performance of the model will be based on its ability to predict iohexol concentrations, expressed through (%) and accuracy (root of mean bias squared = RMSE) between urinary concentrations and predicted plasma levels and urinary concentrations and observed plasma levels.
Measured: 0 minute, 15 minutes, 30 minutes, 1 hour, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hrs
Evaluate the correlation between plasma clearance of iohexol obtained by the model and The GFR estimated by (CKD-EPI formula B, MDRD4 and MDRD6 formulas C, renal clearance of cystatine C)
Linear Correlation Coefficients and Point Clouds between the plasma clearance of iohexol estimated by model and the DFGs calculated by the different methods. Bland Altman curves will also be drawn.
Measured: 0 minute, 24 hours
Determine in the model of plasmatic clearance the relevant covariates.
Evaluation of covariates by multiple linear regression and point clouds (continuous covariates) or Mann Whitney and box plots (categorical covariates). Inclusion of covariates characterized by a P <0.01 in the model. Looking for covariates that will influence the relationship between plasma clearance and renal clearance : grade of intensity of ascites. 2 grades: minimal, (ultrasound) or moderate and bulky, age, weight (of the day and H24), sex, diuresis of 24 hours, albumin, natriuresis, taking diuretics (nature and dose), other drugs that can influence GFR, biological stigmata of hepatic insufficiency or portal hypertension: bilirubin, albumin, INR, phosphatases, Child Pugh score, MELD score.
Measured: 0 minute, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start2 Jan 2019
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis RenalStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769597
- Sponsor's protocol ID
- 87RI18_0007 (DFG HEP)
- Acronym
- DFG HEP
- Status last verified
- Aug 2018
- First submitted
- 30 Nov 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Evolution of Plasma and Urinary Concentrations of Iohexol in a Cirrhotic Patient Population: "Pilot Study on 9 Patients"
- ClinicalTrials.gov ID
- NCT03769597
- Acronym / sponsor ID
- DFG HEP / 87RI18_0007 (DFG HEP)
- Conditions
- Cirrhosis Renal
- Keywords
- Cirrhosis Renal, GFR, renal function, Bayesian model, plasma clearance, iohexol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 7 Dec 2018 (actual)
- 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.
Background: It is important to accurately assess the glomerular filtration rate (GFR) of patients with liver diseases, particularly cirrhosis, to deliver care and adjust the drugs' posology.
Purpose: The frequency of chronic renal failure is underestimated in patients with advanced liver disease and the difficulty to assess kidney failure justifies the investigator's study, which aims to describe, by means of a population pharmacokinetic model, the evolution of plasma and urinary concentrations of iohexol, an effective non-ionic, water-soluble contrast agent which is used in radiographic procedures, in cirrhotic patients.
Detailed description
Cirrhosis is often complicated by kidney failure and the prognostic value of renal function (serum creatinine) during cirrhosis is included in the MELD model. In addition, chronic kidney disease (15%) after liver transplantation is also an independent mortality factor.
The most commonly used methods to estimate GFR are based on creatinine, but in patients suffering from advanced hepatic disease, such as cirrhosis, this parameter is incorrect, due to the low creatinine production and potentially to elevated serum bilirubin and decreased albumin levels. Furthermore, ascites can interfere with serum creatinine concentration. In this condition, all creatinine-based evaluations of GFR overestimate gold standard-measured GFR. Specific eGFR equations for liver disease or new approaches for estimating GFR may be necessary.
The plasma clearance of iohexol is a recognized technique for the measurement of the glomerular filtration rate (GFR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iohexol administration | Experimental | Drug: Iohexol Inj 300 MG/MLAfter injecting a loading dose of 5ml of Iohexol Inj 300 MG/ML bolus, blood samples will be taken at given times for 24 hours. The urinary samples will be taken at each urination, with measurement of the exact volume and times |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with advanced liver disease, with potential indication for liver transplantation, with or without ascites :
- Patients will be over 18 years, affiliated to a social security scheme and give their informed consent.
Key exclusion criteria (15 listed)
- Hypersensitivity to the active substance to the products of iodinated contrasts or to any of the excipients mentioned in Composition section
- History of major or cutaneous immediate reaction delayed injection of iodinated contrast medium (Omnipaque)
- Patients with thyrotoxicosis
- Asthmatic patients
- Patient with a history of dysthyroidism
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 |
|---|---|---|
| Iohexol Inj 300 MG/MLAfter injecting a loading dose of 5ml of iohexol bolus, blood samples will be taken at given times for 24 hours. The urinary samples will be taken at each urination, with measurement of the exact volume and times | Drug | Iohexol administration |
Primary outcome
Change of plasma concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.
Time frame: 0 minute, 15 minute, 30 minute, 1 hour, 90 minute, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Plasma concentration curves for iohexol according to the time.
Change of urinary concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics.
Time frame: 0 minute, 4 hours, 8 hours, 12 hours, 24 hours
Urine concentration curves for iohexol according to the time.
5 secondary outcomes
Calculate the renal clearance of iohexol.
Time frame: 0 minute, 15 minute, 30 minute, 1 hour, 90 minute, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Calculate the plasma clearance of iohexol.
Time frame: 0 minute, 15 minutes, 30 minutes, 1 hour, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours
Develop a pharmacokinetic model for the estimation of renal clearance from plasma clearance.
Time frame: 0 minute, 15 minutes, 30 minutes, 1 hour, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hrs
Evaluate the correlation between plasma clearance of iohexol obtained by the model and The GFR estimated by (CKD-EPI formula B, MDRD4 and MDRD6 formulas C, renal clearance of cystatine C)
Time frame: 0 minute, 24 hours
Determine in the model of plasmatic clearance the relevant covariates.
Time frame: 0 minute, 24 hours
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 25 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Iohexol Inj 300 MG/ML in people with Cirrhosis Renal, run by University Hospital, Limoges at 1 site in France.
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 5 inclusion and 15 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 25 Sep 2019. 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 France. 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.
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?
Change of plasma concentrations of iohexol in a population of 9 cirrhotic patients from rich kinetics. (time frame: 0 minute, 15 minute, 30 minute, 1 hour, 90 minute, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours). The study lists 2 primary outcomes in all. 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 25 Sep 2019.