Autosomal Dominant Polycystic Kidney DiseasePhase 3EVERKYSTENCT02134899
The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients
A Phase 3 study testing Everolimus and Calcineurin inhibitors maintenance in people with Autosomal Dominant Polycystic Kidney Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The investigators multicenter randomized open-labelled study will investigate the efficacy of an everolimus based immunosuppression in reducing total native kidney volume in kidney recipients with autosomal dominant polycystic kidney disease compared to a calcineurin inhibitor-based immunosuppression. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- What is being tested?
- Everolimus and Calcineurin inhibitors maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2014to 11 Nov 2017
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 75 years-old
- recipients of a first kidney graft between 6 month and 5 years ago with a stable eGFR above 30 ml/min/1,73m2
- contraception for female recipients to avoid pregnancy
- valid health Insurance during the study period
Who cannot join
- signed informed consent not obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney Disease
The investigators multicenter randomized open-labelled study will investigate the efficacy of an everolimus based immunosuppression in reducing total native kidney volume in kidney recipients with autosomal dominant polycystic kidney disease compared to a calcineurin inhibitor-based immunosuppression.
Read the detailed description
Kidney graft recipients receiving a firs kidney graft (between 6 months and 5 years post-transplantation) will be randomized 1:1 to receive an everolimus based immunosuppression (in association with steroids and mycophenolate mofetil) or to continue their calcineurin inhibitor-based immunosuppression regimen. The primary objective will be the reduction of total native kidney volume after a 2-years treatment period.
- Being tested
- Everolimus, Calcineurin inhibitors maintenance
- Keywords
- Autosomal dominant polycystic kidney disease, cyst, kidney, liver, kidney transplantation, IF/TA, fibrosis, DSA, mTOR inhibitors, calcineurin inhibitors
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Cysts, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called everolimus conversion
Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression
Calcineurin inhibitors maintenanceDrug
Also called calcineurin-inhibitors based immunosuppression
Usual treatment
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | everolimus based immunosuppression Receives: Drug: Everolimus |
| Calcineurin | Active comparator | Calcineurin inhibitors maintenance Receives: Drug: Calcineurin inhibitors maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total native kidney volume variation
measurements of total native kidney volume with a MRI
Measured: 24 months after randomization
Secondary outcomes (10)
Volume variation of the biggest liver cyst
Measurements of the biggest liver cyst volume with a MRI
Measured: 24 months after randomization
Interstitial Fibrosis/Tubular Atrophy variation
IF/TA quantification using Banff criteria during a kidney biopsy
Measured: 24 months after randomization
% interstitial fibrosis using Red Sirius staining
% fibrosis quantified using a morphometry software
Measured: 24 months after randomization
Calculated Estimated Glomerular Filtration rate
calculated estimated GFR
Measured: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Measured Glomerular Filtration rate
measured GFR
Measured: At baseline and 24 months
Proteinuria
Measurement
Measured: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
systolic and diastolic blood pressure
Clinic measurement
Measured: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Occurrence of diabetes or hyperlipidemia
Measurements
Measured: up to 24 months
Occurrence of neoplasia
Medical chart reporting
Measured: up to 24 months
Development of HLA Donor Specific Antibody (DSA)
V0, 1 year and 2 years after randomization
Measured: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study start14 Oct 2014
- Primary completion11 Nov 2017
- Study completion11 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Hélène François, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134899
- Sponsor's protocol ID
- P 090804
- Other IDs
- 2012-004265-41
- Acronym
- EVERKYSTE
- Status last verified
- Dec 2018
- First submitted
- 28 Apr 2014
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney Disease
- ClinicalTrials.gov ID
- NCT02134899
- Acronym / sponsor ID
- EVERKYSTE / P 090804
- Keywords
- Autosomal dominant polycystic kidney disease, cyst, kidney, liver, kidney transplantation, IF/TA, fibrosis, DSA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 14 Oct 2014 (actual)
- Primary completion
- 11 Nov 2017 (actual)
- Study completion
- 11 Nov 2017 (actual)
- First posted
- 9 May 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 investigators multicenter randomized open-labelled study will investigate the efficacy of an everolimus based immunosuppression in reducing total native kidney volume in kidney recipients with autosomal dominant polycystic kidney disease compared to a calcineurin inhibitor-based immunosuppression.
Detailed description
Kidney graft recipients receiving a firs kidney graft (between 6 months and 5 years post-transplantation) will be randomized 1:1 to receive an everolimus based immunosuppression (in association with steroids and mycophenolate mofetil) or to continue their calcineurin inhibitor-based immunosuppression regimen. The primary objective will be the reduction of total native kidney volume after a 2-years treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Drug: Everolimuseverolimus based immunosuppression |
| Calcineurin | Active comparator | Drug: Calcineurin inhibitors maintenanceCalcineurin inhibitors maintenance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 75 years-old
- recipients of a first kidney graft between 6 month and 5 years ago with a stable eGFR above 30 ml/min/1,73m2
- contraception for female recipients to avoid pregnancy
- valid health Insurance during the study period
Key exclusion criteria (1 listed)
- signed informed consent not obtained
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 |
|---|---|---|
| EverolimusAlso: everolimus conversionChange from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression | Drug | Everolimus |
| Calcineurin inhibitors maintenanceAlso: calcineurin-inhibitors based immunosuppressionUsual treatment | Drug | Calcineurin |
Primary outcome
Total native kidney volume variation
Time frame: 24 months after randomization
measurements of total native kidney volume with a MRI
10 secondary outcomes
Volume variation of the biggest liver cyst
Time frame: 24 months after randomization
Interstitial Fibrosis/Tubular Atrophy variation
Time frame: 24 months after randomization
% interstitial fibrosis using Red Sirius staining
Time frame: 24 months after randomization
Calculated Estimated Glomerular Filtration rate
Time frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Measured Glomerular Filtration rate
Time frame: At baseline and 24 months
Proteinuria
Time frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
systolic and diastolic blood pressure
Time frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
Occurrence of diabetes or hyperlipidemia
Time frame: up to 24 months
Occurrence of neoplasia
Time frame: up to 24 months
Development of HLA Donor Specific Antibody (DSA)
Time frame: At baseline, 1 month, 6 months, 12 months, 18 and 24 months
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 10 Dec 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.
Hélène François, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus and Calcineurin inhibitors maintenance in people with Autosomal Dominant Polycystic Kidney Disease, run by Assistance Publique - Hôpitaux de Paris 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 1 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 10 Dec 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Total native kidney volume variation (time frame: 24 months after randomization). 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 10 Dec 2018.