Kidney TransplantDRUGTOXNCT04963673
Evaluation of Interaction Between Immunosuppressive Drugs and Protein-bound Uremic Toxins in Renal Transplant Patients
An observational study of Kidney Transplant and Immunosuppression, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The majority of studies conducted on uremic toxins involve patients before end stage renal failure or dialysis patients. Only a few studies have focused on transplant patients. In addition, the relationship between serum concentrations of uremic toxins and immunosuppressive drug concentrations has never been studied… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Immunosuppression, Uremic; Toxemia
- What is being tested?
- calcineurin inhibitor dosage
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2021to 12 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant population followed at CHU Amiens (group 1 ⇾ DFG> 40 ml / min, group 2 ⇾ DFG < 40 ml / min).
Who may be able to join
- renal transplant patient followed at the University Hospital of Amiens and transplanted for over a year
- patient treated with a calcineurin inhibitor
- patient having a blood test for evaluation of calcineurin inhibitor concentrations by the toxicology pharmacology laboratory of the Amiens-Picardie University Hospital,
- patient affiliated with social security.
Who cannot join
- patient in phase of acute rejection of the graft,
- patient having opposed his participation,
- patient under guardianship or curatorship or deprived of public right
Trial locations and contacts
1 site in 1 country.
About this study
The majority of studies conducted on uremic toxins involve patients before end stage renal failure or dialysis patients. Only a few studies have focused on transplant patients. In addition, the relationship between serum concentrations of uremic toxins and immunosuppressive drug concentrations has never been studied to date.
The investigator research hypothesis is that, due to the strong plasma protein binding of calcineurin inhibitors, an interaction with protein-bound uremic toxins could alter drug concentrations that explain difficulties in reaching therapeutic targets.
Read the detailed description
In France, the national prevalence of end-stage kidney disease (including dialysis and renal transplantation) is 1,232 per million inhabitants. As in all transplants, renal transplantation needs immunosuppressive therapy. This treatment may be difficult to adjust in some patients. However, achieving the therapeutic target is essential to have an efficiency synonymous with graft survival and better tolerance to the drug. The immunosuppressive class drug of interest in the present project is the class of calcineurin inhibitors (tacrolimus and ciclosporin) that are widely used in both initial and maintenance immunosuppression. These drugs have the pharmacological specificities to be highly bound to plasma proteins and requiring pharmacological therapeutic monitoring.
With the progression of chronic kidney disease, many molecules accumulate as a result of decreased kidney excretion capacity, such as compounds called uremic toxins. The investigators research is part of the European network for the study of these toxins (Eutox group) and has largely contributed to the better knowledge of these toxins. In particular, they are defined by their dose-dependent deleterious effects. These molecules are classified, according to their molecular weight, into small molecules, medium molecules and molecules strongly bound to plasma proteins (p-cresyl sulphate [pCS], indoxyl sulphate [IS] and indol acetic acid [IAA]). This last group of protein will be evaluated in this project.
The majority of studies conducted on uremic toxins involve patients before end stage renal failure or dialysis patients. Only a few studies have focused on transplant patients. In addition, the relationship between serum concentrations of uremic toxins and immunosuppressive drug concentrations has never been studied to date.
the investigator research hypothesis is that, due to the strong plasma protein binding of calcineurin inhibitors, an interaction with protein-bound uremic toxins could alter drug concentrations that explain difficulties in reaching therapeutic targets.
- Conditions
- Kidney Transplant, Immunosuppression, Uremic; Toxemia
- Being tested
- calcineurin inhibitor dosage
- Keywords
- Kidney Transplant, Immunosuppression, Uremic; Toxemia
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcineurin inhibitor dosageOther
The dosage of calcineurin inhibitors will be done as usual by the toxicology pharmacology laboratory of the CHU Amiens-Picardie. If the patient does not object, the determination of protein-bound uremic toxins from the rest of the collected blood tube will be performed using high performance liquid chromatography.
| Study group | Role | What they receive |
|---|---|---|
| DFG> 40 ml / min | Kidney transplant population followed at CHU Amiens (group 1 ⇾ DFG> 40 ml / min). Receives: Other: calcineurin inhibitor dosage | |
| DFG < 40 ml / min | Kidney transplant population followed at CHU Amiens (group 2 ⇾ DFG < 40 ml / min). Receives: Other: calcineurin inhibitor dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma tacrolimus concentration without plasma uremic toxin adjustment
Measured: at day 0
plasma tacrolimus concentration with plasma uremic toxin adjustment
Measured: at day 0
Secondary outcomes (2)
plasma ciclosporin concentration without plasma uremic toxin adjustment
Measured: at day 0
plasma ciclosporin concentration with plasma uremic toxin adjustment
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start6 Jul 2021
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youssef Bennis, MD, Principal investigator, CHU AmiensSandra Bodeau, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963673
- Sponsor's protocol ID
- PI2019_843_0060
- Acronym
- DRUGTOX
- Status last verified
- Sep 2023
- First submitted
- 6 Jul 2021
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Interaction Between Immunosuppressive Drugs and Protein-bound Uremic Toxins in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT04963673
- Acronym / sponsor ID
- DRUGTOX / PI2019_843_0060
- Conditions
- Kidney Transplant, Immunosuppression, Uremic; Toxemia
- Keywords
- Kidney Transplant, Immunosuppression, Uremic; Toxemia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 15 Jul 2021 (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.
The majority of studies conducted on uremic toxins involve patients before end stage renal failure or dialysis patients. Only a few studies have focused on transplant patients. In addition, the relationship between serum concentrations of uremic toxins and immunosuppressive drug concentrations has never been studied to date.
The investigator research hypothesis is that, due to the strong plasma protein binding of calcineurin inhibitors, an interaction with protein-bound uremic toxins could alter drug concentrations that explain difficulties in reaching therapeutic targets.
Detailed description
In France, the national prevalence of end-stage kidney disease (including dialysis and renal transplantation) is 1,232 per million inhabitants. As in all transplants, renal transplantation needs immunosuppressive therapy. This treatment may be difficult to adjust in some patients. However, achieving the therapeutic target is essential to have an efficiency synonymous with graft survival and better tolerance to the drug. The immunosuppressive class drug of interest in the present project is the class of calcineurin inhibitors (tacrolimus and ciclosporin) that are widely used in both initial and maintenance immunosuppression. These drugs have the pharmacological specificities to be highly bound to plasma proteins and requiring pharmacological therapeutic monitoring.
With the progression of chronic kidney disease, many molecules accumulate as a result of decreased kidney excretion capacity, such as compounds called uremic toxins. The investigators research is part of the European network for the study of these toxins (Eutox group) and has largely contributed to the better knowledge of these toxins. In particular, they are defined by their dose-dependent deleterious effects. These molecules are classified, according to their molecular weight, into small molecules, medium molecules and molecules strongly bound to plasma proteins (p-cresyl sulphate [pCS], indoxyl sulphate [IS] and indol acetic acid [IAA]). This last group of protein will be evaluated in this project.
The majority of studies conducted on uremic toxins involve patients before end stage renal failure or dialysis patients. Only a few studies have focused on transplant patients. In addition, the relationship between serum concentrations of uremic toxins and immunosuppressive drug concentrations has never been studied to date.
the investigator research hypothesis is that, due to the strong plasma protein binding of calcineurin inhibitors, an interaction with protein-bound uremic toxins could alter drug concentrations that explain difficulties in reaching therapeutic targets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFG> 40 ml / min | – | Other: calcineurin inhibitor dosageKidney transplant population followed at CHU Amiens (group 1 ⇾ DFG> 40 ml / min). |
| DFG < 40 ml / min | – | Other: calcineurin inhibitor dosageKidney transplant population followed at CHU Amiens (group 2 ⇾ DFG < 40 ml / min). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant population followed at CHU Amiens (group 1 ⇾ DFG> 40 ml / min, group 2 ⇾ DFG < 40 ml / min).
Key inclusion criteria (4 listed)
- renal transplant patient followed at the University Hospital of Amiens and transplanted for over a year
- patient treated with a calcineurin inhibitor
- patient having a blood test for evaluation of calcineurin inhibitor concentrations by the toxicology pharmacology laboratory of the Amiens-Picardie University Hospital,
- patient affiliated with social security.
Key exclusion criteria (3 listed)
- patient in phase of acute rejection of the graft,
- patient having opposed his participation,
- patient under guardianship or curatorship or deprived of public right
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 |
|---|---|---|
| calcineurin inhibitor dosageThe dosage of calcineurin inhibitors will be done as usual by the toxicology pharmacology laboratory of the CHU Amiens-Picardie. If the patient does not object, the determination of protein-bound uremic toxins from the rest of the collected blood tube will be performed using high performance liquid chromatography. | Other | DFG < 40 ml / min, DFG> 40 ml / min |
Primary outcome
plasma tacrolimus concentration without plasma uremic toxin adjustment
Time frame: at day 0
plasma tacrolimus concentration with plasma uremic toxin adjustment
Time frame: at day 0
2 secondary outcomes
plasma ciclosporin concentration without plasma uremic toxin adjustment
Time frame: at day 0
plasma ciclosporin concentration with plasma uremic toxin adjustment
Time frame: at day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Youssef Bennis, MD principal investigator
CHU Amiens
Sandra Bodeau, MD principal investigator
CHU Amiens
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 Kidney Transplant and Immunosuppression, run by Centre Hospitalier Universitaire, Amiens 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Sep 2023. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
plasma tacrolimus concentration without plasma uremic toxin adjustment (time frame: at day 0). 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 14 Sep 2023.