Renal TransplantationCATAPULTNCT02843295
Catalytic Antibodies to Predict Uninvasively Late Transplant Failure
A study testing blood samples in people with Renal Transplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is characterized by a progressive decline in graft function correlating with tissue destruction. Recent data suggest that it may be possible to delay graft destruction if adequate management is initiated early (ie, at the stage of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplantation
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Sep 2015
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18 the day of transplantation
- Recipient of a renal graft
- Informed consent to participate to the study
- Patient transplanted and followed 2 years in one of the 3 transplantation centers of the study (Hospital Edouard Herriot or Centre Hospitalier Lyon Sud)
Who cannot join
- Multiorgan transplantation
- Previous transplantation
- ABO incompatible renal transplantation
- Patient > 18 years old but under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is characterized by a progressive decline in graft function correlating with tissue destruction. Recent data suggest that it may be possible to delay graft destruction if adequate management is initiated early (ie, at the stage of subclinical CAN). It is therefore essential to design new tests allowing physicians to predict transplant recipients prone to develop CAN
Read the detailed description
Superantibodies are multifunctional antibodies combining the classical antigen-binding function with nonclassical biological activities, such as protease-like activity. In the past few years the role of proteolytic SuperAntibody (pSAb) has been evidenced in many biological processes in which their role may be either deleterious (autoimmune disease, alloimmune response against) or beneficial (sepsis).
Nothing is known so far regarding the role of pSAb in the setting of solid organ transplantation.
Preliminary data
The investigator has obtained preliminary results from a retrospective case control study indicating that an elevated serine protease activity of circulating IgG (measured by the hydrolysis of a synthetic fluorescent substrate: Proline-Phenylalanine-Arginine-Methylcoumarinamide (PFR-MCA)), correlates with the absence of CAN on protocol biopsy performed 2 years post-transplantation. Interestingly, low level of proteolysis IgG, measured 3 months post-transplantation, were also predictive of CAN at 2 years down the lane.
Aim of the Research project:
The aim is to validate in a prospective study, the potential of pSAb as predictive marker for CAN
100 recipients of a renal graft have to be enrolled and followed for 2 years.
The level of PFR-MCA hydrolysis by circulating Immunoglobulin G (IgG) will be measured before the transplantation and every 3 months up to one year and every 6 months thereafter until 2 year post-transplantation. The development of CAN will be assessed by estimated glomerular filtration rate (Modification of the Diet in Renal Disease (MDRD) formula), the proteinuria and the histological examination of the graft (screening biopsy at 3 months and 1 year will be analysed using a computerized color image analysis to quantify interstitial fibrosis).
The capacity of the pSAb test to predict CAN will be validated and the sensibility and specificity of this test will be calculated. The optimal cut-off value will be determined from the Receiver Operating Characteristic (ROC) analysis. The accuracy of the test will be evaluated in subgroups displaying various risk factors for CAN.
- Conditions
- Renal Transplantation
- Being tested
- blood samples
- Keywords
- renal transplantation, immunology, rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Population of the study | Experimental | 3 stratification groups: Group 1: High immunologic risk Patients receiving a ≥ 2nd graft and/or Panel Reactive Antibody ≥ 30% and/or Human Leukocyte Antigen (HLA) mismatches ≥ 4 Group 2: High non-immunologic risk Donors over 60 years of age and/or Donor between 50 to 59 years of age who have died of stroke, or had a history of high blood pressure, or at the time of death had a creatininemia ≥ 135 µmol/L Group 3: Low risk Patients not included in Groups 1 or 2 Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Measured: at 3 months post-transplantation
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Measured: at 6 months post-transplantation
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Measured: at 9 months post-transplantation
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Measured: at 12 months post-transplantation
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Measured: at 18 months post-transplantation
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Measured: at 24 months post-transplantation
Secondary outcomes (15)
Glomerular filtration rate by MDRD formula (ml/min)
Measured: at 3 months post-transplantation
Glomerular filtration rate by MDRD formula (ml/min)
Measured: at 6 months post-transplantation
Glomerular filtration rate by MDRD formula (ml/min)
Measured: at 9 months post-transplantation
Glomerular filtration rate by MDRD formula (ml/min)
Measured: at 12 months post-transplantation
Glomerular filtration rate by MDRD formula (ml/min)
Measured: at 18 months post-transplantation
Glomerular filtration rate by MDRD formula (ml/min)
Measured: at 24 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Measured: at 3 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Measured: at 6 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Measured: at 9 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Measured: at 12 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Measured: at 18 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Measured: at 24 months post-transplantation
Interstitial fibrosis on graft biopsy (%)
Measured: at day 0
Interstitial fibrosis on graft biopsy (%)
Measured: at 12 months post-transplantation
Interstitial fibrosis on graft biopsy (%)
Measured: at 24 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startSep 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier THAUNAT, MD, Principal investigator, Hospices Civils de Lyon - Transplantation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843295
- Sponsor's protocol ID
- 2009-592
- Acronym
- CATAPULT
- Status last verified
- Aug 2016
- First submitted
- 21 Jul 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catalytic Antibodies to Predict Uninvasively Late Transplant Failure
- ClinicalTrials.gov ID
- NCT02843295
- Acronym / sponsor ID
- CATAPULT / 2009-592
- Conditions
- Renal Transplantation
- Keywords
- renal transplantation, immunology, rejection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Jul 2016 (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.
Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is characterized by a progressive decline in graft function correlating with tissue destruction. Recent data suggest that it may be possible to delay graft destruction if adequate management is initiated early (ie, at the stage of subclinical CAN). It is therefore essential to design new tests allowing physicians to predict transplant recipients prone to develop CAN
Detailed description
Superantibodies are multifunctional antibodies combining the classical antigen-binding function with nonclassical biological activities, such as protease-like activity. In the past few years the role of proteolytic SuperAntibody (pSAb) has been evidenced in many biological processes in which their role may be either deleterious (autoimmune disease, alloimmune response against) or beneficial (sepsis).
Nothing is known so far regarding the role of pSAb in the setting of solid organ transplantation.
Preliminary data
The investigator has obtained preliminary results from a retrospective case control study indicating that an elevated serine protease activity of circulating IgG (measured by the hydrolysis of a synthetic fluorescent substrate: Proline-Phenylalanine-Arginine-Methylcoumarinamide (PFR-MCA)), correlates with the absence of CAN on protocol biopsy performed 2 years post-transplantation. Interestingly, low level of proteolysis IgG, measured 3 months post-transplantation, were also predictive of CAN at 2 years down the lane.
Aim of the Research project:
The aim is to validate in a prospective study, the potential of pSAb as predictive marker for CAN
100 recipients of a renal graft have to be enrolled and followed for 2 years.
The level of PFR-MCA hydrolysis by circulating Immunoglobulin G (IgG) will be measured before the transplantation and every 3 months up to one year and every 6 months thereafter until 2 year post-transplantation. The development of CAN will be assessed by estimated glomerular filtration rate (Modification of the Diet in Renal Disease (MDRD) formula), the proteinuria and the histological examination of the graft (screening biopsy at 3 months and 1 year will be analysed using a computerized color image analysis to quantify interstitial fibrosis).
The capacity of the pSAb test to predict CAN will be validated and the sensibility and specificity of this test will be calculated. The optimal cut-off value will be determined from the Receiver Operating Characteristic (ROC) analysis. The accuracy of the test will be evaluated in subgroups displaying various risk factors for CAN.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population of the study | Experimental | Other: blood samples3 stratification groups: Group 1: High immunologic risk Patients receiving a ≥ 2nd graft and/or Panel Reactive Antibody ≥ 30% and/or Human Leukocyte Antigen (HLA) mismatches ≥ 4 Group 2: High non-immunologic risk Donors over 60 years of age and/or Donor between 50 to 59 years of age who have died of stroke, or had a history of high blood pressure, or at the time of death had a creatininemia ≥ 135 µmol/L Group 3: Low risk Patients not included in Groups 1 or 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 the day of transplantation
- Recipient of a renal graft
- Informed consent to participate to the study
- Patient transplanted and followed 2 years in one of the 3 transplantation centers of the study (Hospital Edouard Herriot or Centre Hospitalier Lyon Sud)
Key exclusion criteria (4 listed)
- Multiorgan transplantation
- Previous transplantation
- ABO incompatible renal transplantation
- Patient > 18 years old but under guardianship
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 |
|---|---|---|
| blood samples | Other | Population of the study |
Primary outcome
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Time frame: at 3 months post-transplantation
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Time frame: at 6 months post-transplantation
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Time frame: at 9 months post-transplantation
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Time frame: at 12 months post-transplantation
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Time frame: at 18 months post-transplantation
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol)
Time frame: at 24 months post-transplantation
15 secondary outcomes
Glomerular filtration rate by MDRD formula (ml/min)
Time frame: at 3 months post-transplantation
Glomerular filtration rate by MDRD formula (ml/min)
Time frame: at 6 months post-transplantation
Glomerular filtration rate by MDRD formula (ml/min)
Time frame: at 9 months post-transplantation
Glomerular filtration rate by MDRD formula (ml/min)
Time frame: at 12 months post-transplantation
Glomerular filtration rate by MDRD formula (ml/min)
Time frame: at 18 months post-transplantation
Glomerular filtration rate by MDRD formula (ml/min)
Time frame: at 24 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Time frame: at 3 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Time frame: at 6 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Time frame: at 9 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Time frame: at 12 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Time frame: at 18 months post-transplantation
Proteinuria/creatinuria ratio (g/g)
Time frame: at 24 months post-transplantation
Interstitial fibrosis on graft biopsy (%)
Time frame: at day 0
Interstitial fibrosis on graft biopsy (%)
Time frame: at 12 months post-transplantation
Interstitial fibrosis on graft biopsy (%)
Time frame: at 24 months post-transplantation
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 Aug 2016.
- 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.
Olivier THAUNAT, MD principal investigator
Hospices Civils de Lyon - Transplantation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Renal Transplantation, run by Hospices Civils de Lyon 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 4 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 Aug 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 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 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?
PFR-MCA hydrolysis by circulating IgG (mmol/min/mol) (time frame: at 3 months post-transplantation). The study lists 6 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 Aug 2016.