Renal Insufficiency, ChronicPhase 1/2MultiGFRNCT02286258
Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR)
A Phase 1/2 study testing Calcium EDTA and Gd-DOTA in people with Renal Insufficiency, Chronic and Kidney Diseases, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
The purpose of this study is to validate in comparison to a reference method (inuline) two novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic, Kidney Diseases
- What is being tested?
- Calcium EDTA and Gd-DOTA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2014to Feb 2017
- Phase
- Phase 1/2
- 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
Who may be able to join
- males or females without pregnancy
- age : 18-75
- stable chronic kidney disease stages 1 to 4 (MDRD KDIGO 2005), estimated GFR > 15 mL/min/1.73m²
- clinical GFR measurement indication
- males, 18-35 years old
- weight : 60-100 kg , BMI 18-27 kg/m²
- estimated GFR > 90 mL/min/1.73 m² (MDRD)
- acute diseases in the previous 7 days
Who cannot join
- kidney transplantation
- allergic
- acute disease leading to acute change in GFR
- heavy metals poisoning (treated or not)
- gadolinium contrast agent in the previous month
- Healthy volunteers :
Show all 10Show fewer
- uro-nephrological disease (past or present)
- nephrotoxic drug chronic use in the previous 2 months
- allergic
- systemic disease (acute or chronic)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hopital Europeen Georges Pompidou (centre d'investigations cliniques)
Paris, 75015
Hopital Europeen Georges Pompidou (Service de Nephrologie)
Paris, 75015
Hopital Europeen Georges Pompidou (service de Physiologie et des Radioisotopes)
Paris, 75015
CHU Rangueil (service explorations fonctionnelles physiologiques)
Toulouse, 31059
About this study
Official title: MultiGFR: Equivalency Study of Different Methods of Measuring Glomerular Filtration Rate
The purpose of this study is to validate in comparison to a reference method (inuline) two novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.
Read the detailed description
Research on estimation and measurement of renal function has been greatly stimulated by the international concept of chronic kidney disease (CKD) and its classification into stages of severity based on the level of glomerular filtration rate (GFR) (National Kidney Foundation KDOQI and ANAES in 2002, KDIGO conference in 2005), and by the development of recommendations for clinical practice according to this stages. Many efforts have focused on the validation of new formula to estimate GFR from endogenous markers. Nevertheless, the performance of these formula is limited by a large inter individual variability, that requires in many cases the use of GFR measurement using exogenous tracers (extreme anthropometric characteristics, abnormal production of endogenous tracers, potential kidney donors, dose adjustment, nephrotoxicity monitoring…). The use of GFR measurement is burdened by a lack of availability due to methodological, biological and regulatory (for radioactive tracers) constraints. That's why a need exists for new validated tracers that will be more accessible and easier to use. Moreover, there are differences between the measurement techniques: single injection of the tracer or concentration equilibrium obtained by continuous infusion; plasma or urinary clearance.
Two new tracers for GFR measurement are here offered for validation: Gd-DOTA and Calcium-EDTA. Gd-DOTA is a macrocyclic paramagnetic contrast product, which can be measured using an ELISA type immunoassay. Although being widely used in radiology with higher doses than those that will be used for GFR measurement in the multi-GFR study, Gd-DOTA has never been involved in systemic nephrogenic fibrosis cases (ProFinest study). Calcium-EDTA has been used for many years for the chelation of heavy metals. Recently, a colorimetric assay for Calcium-EDTA measurement has been developed. Gd-DOTA and Calcium-EDTA clearance for GFR measurement will be compared to inuline clearance in healthy volunteers (25 for each new tracer) and CKD patients (150 for each new tracer).
- Conditions
- Renal Insufficiency, Chronic, Kidney Diseases
- Being tested
- Calcium EDTA, Gd-DOTA
- Keywords
- Inulin, Ca-EDTA, Gd-DOTA, Chronic kidney disease, glomerular filtration rate measurement
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium EDTADrug
Also called Edetic Acid, Calcium, Sodium Salt, Edetate Disodium Calcium
Calcium EDTA for equilibrium GFR measurement : bolus injection 30 mg/kg, then 10 mg/min perfusion for estimated renal clearance 100 mL /min for 4 hours.
Calcium EDTA for single injection GFR measurement : bolus injection depending on the estimated GFR
Gd-DOTADrug
Also called gadoterate, dotarem, Dota gadolinium
Gd-DOTA for equilibrium GFR measurement : bolus injection 56 ng/kg, then 28 ng/min perfusion for estimated renal clearance 100 mL /min for 4 hours.
Gd-DOTA for single injection GFR measurement : bolus injection depending on the estimated GFR
| Study group | Role | What they receive |
|---|---|---|
| Inuline - Calcium EDTA | Experimental | Calcium EDTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers and CKD patients (stage 1 to 4). Receives: Drug: Calcium EDTA |
| Inuline - Gd-DOTA | Experimental | Gd-DOTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers and CKD patients (stage 1 to 4). Receives: Drug: Gd-DOTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium EDTA and Gd-DOTA clearance for glomerular filtration rate measurement
Calcium EDTA or Gd-DOTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers (n= 25) and in CKD patients (n= 150, stages 1 to 4, 30 patients for each stage) at equilibrium by measuring urinary clearances of inuline and Calcium EDTA or Gd-DOTA continuously co-infused after a loading dose.
Measured: 1 day
Secondary outcomes (5)
Calcium EDTA and Gd-DOTA clearance for glomerular filtration rate measurement in each CKD stage
Calcium EDTA or Gd-DOTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers (n= 25) and in CKD patients (n= 150, stages 1 to 4, 30 patients for each stage) at equilibrium by measuring urinary clearances of inuline and Calcium EDTA or Gd-DOTA continuously co-infused after a loading dose.
Measured: 1 day
Calcium EDTA and Gd-DOTA clearance reproducibility for GFR measurement
Calcium EDTA or Gd-DOTA clearance is measured twice at day 1 and day 15 in healthy volunteers (n= 25) and in CKD patients (n= 25, stages 1 to 4, 5 patients for each stage) at equilibrium by measuring urinary clearances of inuline and Calcium EDTA or Gd-DOTA continuously co-infused after a loading dose.
Measured: 15 days
Calcium EDTA and Gd-DOTA clearance with single injection for GFR measurement
Calcium EDTA or Gd-DOTA clearance is measured twice at day 1 and day 15 in healthy volunteers (n= 25) and in CKD patients (n= 25, stages 1 to 4, 5 patients for each stage) at equilibrium at day 1 by measuring urinary clearances of inuline and Calcium EDTA or Gd-DOTA continuously co-infused after a loading dose and at day 15 with a single loading dose of Calcium EDTA or Gd-DOTA
Measured: 15 days
Volumes of distribution of Calcium EDTA and Gd-DOTA
Calcium EDTA or Gd-DOTA apparent volumes of distribution are compared to inuline apparent volume of distribution in healthy volunteers (n= 25) and in CKD patients (n= 150, stages 1 to 4, 30 patients for each stage).
Measured: 1 day
Number of participants with adverse events as a measure of safety.
Each event following Calcium EDTA or Gd-DOTA infusion will be listed in healthy volunteers (n = 50) and in patients (n = 300).
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: The study was suspended after a suspected unexpected serious adverse event.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Marie Courbebaisse, Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286258
- Sponsor's protocol ID
- P100151
- Acronym
- MultiGFR
- Status last verified
- May 2018
- First submitted
- 29 Oct 2014
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MultiGFR: Equivalency Study of Different Methods of Measuring Glomerular Filtration Rate
- ClinicalTrials.gov ID
- NCT02286258
- Acronym / sponsor ID
- MultiGFR / P100151
- Conditions
- Renal Insufficiency, Chronic, Kidney Diseases
- Keywords
- Inulin, Ca-EDTA, Gd-DOTA, Chronic kidney disease, glomerular filtration rate measurement
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was suspended after a suspected unexpected serious adverse event.
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Oct 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 7 Nov 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.
The purpose of this study is to validate in comparison to a reference method (inuline) two novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.
Detailed description
Research on estimation and measurement of renal function has been greatly stimulated by the international concept of chronic kidney disease (CKD) and its classification into stages of severity based on the level of glomerular filtration rate (GFR) (National Kidney Foundation KDOQI and ANAES in 2002, KDIGO conference in 2005), and by the development of recommendations for clinical practice according to this stages. Many efforts have focused on the validation of new formula to estimate GFR from endogenous markers. Nevertheless, the performance of these formula is limited by a large inter individual variability, that requires in many cases the use of GFR measurement using exogenous tracers (extreme anthropometric characteristics, abnormal production of endogenous tracers, potential kidney donors, dose adjustment, nephrotoxicity monitoring…). The use of GFR measurement is burdened by a lack of availability due to methodological, biological and regulatory (for radioactive tracers) constraints. That's why a need exists for new validated tracers that will be more accessible and easier to use. Moreover, there are differences between the measurement techniques: single injection of the tracer or concentration equilibrium obtained by continuous infusion; plasma or urinary clearance.
Two new tracers for GFR measurement are here offered for validation: Gd-DOTA and Calcium-EDTA. Gd-DOTA is a macrocyclic paramagnetic contrast product, which can be measured using an ELISA type immunoassay. Although being widely used in radiology with higher doses than those that will be used for GFR measurement in the multi-GFR study, Gd-DOTA has never been involved in systemic nephrogenic fibrosis cases (ProFinest study). Calcium-EDTA has been used for many years for the chelation of heavy metals. Recently, a colorimetric assay for Calcium-EDTA measurement has been developed. Gd-DOTA and Calcium-EDTA clearance for GFR measurement will be compared to inuline clearance in healthy volunteers (25 for each new tracer) and CKD patients (150 for each new tracer).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inuline - Calcium EDTA | Experimental | Drug: Calcium EDTACalcium EDTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers and CKD patients (stage 1 to 4). |
| Inuline - Gd-DOTA | Experimental | Drug: Gd-DOTAGd-DOTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers and CKD patients (stage 1 to 4). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- males or females without pregnancy
- age : 18-75
- stable chronic kidney disease stages 1 to 4 (MDRD KDIGO 2005), estimated GFR > 15 mL/min/1.73m²
- clinical GFR measurement indication
- males, 18-35 years old
Key exclusion criteria (10 listed)
- kidney transplantation
- allergic
- acute disease leading to acute change in GFR
- heavy metals poisoning (treated or not)
- gadolinium contrast agent in the previous month
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 |
|---|---|---|
| Calcium EDTAAlso: Edetic Acid, Calcium, Sodium Salt, Edetate Disodium CalciumCalcium EDTA for equilibrium GFR measurement : bolus injection 30 mg/kg, then 10 mg/min perfusion for estimated renal clearance 100 mL /min for 4 hours. Calcium EDTA for single injection GFR measurement : bolus injection depending on the estimated GFR | Drug | Inuline - Calcium EDTA |
| Gd-DOTAAlso: gadoterate, dotarem, Dota gadoliniumGd-DOTA for equilibrium GFR measurement : bolus injection 56 ng/kg, then 28 ng/min perfusion for estimated renal clearance 100 mL /min for 4 hours. Gd-DOTA for single injection GFR measurement : bolus injection depending on the estimated GFR | Drug | Inuline - Gd-DOTA |
Primary outcome
Calcium EDTA and Gd-DOTA clearance for glomerular filtration rate measurement
Time frame: 1 day
Calcium EDTA or Gd-DOTA clearance for GFR measurement is compared to inuline clearance in healthy volunteers (n= 25) and in CKD patients (n= 150, stages 1 to 4, 30 patients for each stage) at equilibrium by measuring urinary clearances of inuline and Calcium EDTA or Gd-DOTA continuously co-infused after a loading dose.
5 secondary outcomes
Calcium EDTA and Gd-DOTA clearance for glomerular filtration rate measurement in each CKD stage
Time frame: 1 day
Calcium EDTA and Gd-DOTA clearance reproducibility for GFR measurement
Time frame: 15 days
Calcium EDTA and Gd-DOTA clearance with single injection for GFR measurement
Time frame: 15 days
Volumes of distribution of Calcium EDTA and Gd-DOTA
Time frame: 1 day
Number of participants with adverse events as a measure of safety.
Time frame: 45 days
Results and safety
The study was stopped early (reason given: The study was suspended after a suspected unexpected serious adverse event.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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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.
Marie Courbebaisse, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Calcium EDTA and Gd-DOTA in people with Renal Insufficiency, Chronic and Kidney Diseases, run by Assistance Publique - Hôpitaux de Paris at 4 sites 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The study was suspended after a suspected unexpected serious adverse event.). Results are not available in the source record.
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?
Calcium EDTA and Gd-DOTA clearance for glomerular filtration rate measurement (time frame: 1 day). 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 18 May 2018.