Chronic Kidney DiseasePREDICTIONNCT02055950
Pulsed Perfusion for Marginal Kidneys
An observational study of Chronic Kidney Disease, run by Mario Negri Institute for Pharmacological Research at 2 sites in Italy.
Trial summary
Trends in organ donor pool are characterized by an increasing age and a shift towards cerebrovascular diseases as primary causes of death. As a result, donors older than 60 years nowadays represent more than one fourth of the entire donor pool in Italy. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Storage of kidney in refrigerated solution and Kidney perfused by pulsatile machine
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- Jul 2013to Aug 2018
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are eligible to receive a single or dual transplant from older/marginal deceased donors identified according to the Nord Italia Transplant criteria who consent to receive perfused with a pulsatile machine.
Who may be able to join
- Males and females aged 50 years or more and no more than 10 years older or younger than their corresponding donors;
- First single or double kidney transplant from deceased donors older than 60 years;
- Pre-implantation histologic evaluation and graft selection and allocation based on the histologic score and according to the Nord Italian Transplant (NIT) criteria;
- Written informed consent.
Who cannot join
- Any factor that according to the NIT selection criteria represent a contraindication to receive a deceased donor kidney transplant
- Need for specific de-sensitization protocols because of high immunological risk (according to NIT criteria) or participation in other concomitant intervention studies
- Vascular abnormalities/changes that preclude the possibility to perfuse the kidney grafts by a pulsatile machine
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
A.O. Papa Giovanni XXIII - U.O. Nefrologia e Dialisi/U.O. Chirurgia Pediatrica
Bergamo, 24100
IRCCS Policlinico S.Matteo - UOS trapianto di Rene/U.O. Nefrologia
Pavia, 27100
About this study
Official title: A PROSPECTIVE STUDY TO COMPARE EARLY GRAFT FUNCTION OF RECIPIENTS OF SINGLE OR DUAL KIDNEY ORGANS STORED IN ICE COLD SOLUTION OR PULSED PERFUSION
Trends in organ donor pool are characterized by an increasing age and a shift towards cerebrovascular diseases as primary causes of death. As a result, donors older than 60 years nowadays represent more than one fourth of the entire donor pool in Italy. This, along with an increasing number of patients on the waiting list for transplantation, prompted a growing use of organs from subjects older than 60 years that would have been considered unsuitable years ago. To improve graft outcomes, transplant of two older kidneys in the same recipient has been proposed. To optimize allocation of these organs to single or dual transplantation,a scoring system for kidneys, based on biopsy, with scores ranging from a minimum of 0 (indicating the absence of renal lesions) to a maximum of 12 (indicating the presence of marked changes in the renal parenchyma) has been suggested. According to this panel, kidneys with a score of 4 or lower are predicted to contain enough viable nephrons to be used as single transplants, those with a score of 5, 6, or 7 can be used as dual transplants, kidneys with a score greater than 7 are discarded. The survival of kidney grafts obtained from donors older than 60 years and allocated for single or dual transplantation on the basis of biopsy findings before transplantation was similar to that of single grafts from younger donors. To further improve these results, set-up of strategies to preserve organs is crucial to save the residual nephron mass and optimize outcomes of these marginal grafts. In this regard, over the past 30 years two methods of kidney preservation have been developed. With cold storage, the kidney is flushed once it is removed from the donor and placed in an ice-cooled container with preservation solution. With the use of pulsatile machine perfusion, the kidney is connected to a machine, which pumps a cold solution containing oxygen and nutrients through the kidney. This process allows for metabolism to continue in the kidney with end products being removed. The broad aim of the present study is to evaluate whether pulsatile machine perfusion of kidneys from older/marginal donors may provide better outcomes than static perfusion. To this purpose the outcome of recipients of perfused kidneys will be compared with the outcome of historical controls receiving non-perfused kidney selected and allocated on the basis of the same criteria and matched by gender, age and kidney histologic score.
- Conditions
- Chronic Kidney Disease
- Being tested
- Storage of kidney in refrigerated solution, Kidney perfused by pulsatile machine
- Keywords
- Kidney transplant, Marginal donors, Pulse perfusion, Graft function
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storage of kidney in refrigerated solutionProcedure or surgery
Kidney perfused by pulsatile machineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Kidney perfused by pulsatile machine | Not described Receives: Procedure: Kidney perfused by pulsatile machine | |
| Kidney stored in refrigerated solution | Not described Receives: Procedure: Storage of kidney in refrigerated solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate (GFR)
Measured: 6 months after transplant.
Renal resistance
Renal resistance is measured by graft ultrasound. It ranges from 0 to 1.
Measured: 6 hours after pulsatile machine perfusion
Secondary outcomes (3)
Correlation between renal resistance measured at 6 hours after machine perfusion and renal histological score at pre-transplant biopsy
The severity of changes in kidney at pre-transplant biopsy was quantified by a predefined histologic score. Changes in each evaluated component of the kidney tissue , vessels, glomeruli, tubules, and connective tissue, received a score ranging from 0 to 3. The sum of these scores was defined as the global kidney score, which could range from 0 to 12.
Renal resistance is measured by graft ultrasound. It ranges from 0 to 1.
Measured: 6 hours after pulsatile machine perfusion
Correlation between renal resistances measured at 6 hours after pulsatile machine perfusion and intergraft resistances measured by ultrasound at 7 days and 6 months after transplant.
Renal resistances are measured by graft ultrasound. They range from 0 to 1.
Measured: Changes from 7 days at 6 months after transplant .
Incidence of delayed graft function (DGF).
Measured: Within the first week after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Sponsor
- Investigators
- Paolo Cravedi, MD, Study chair, IRCCS - Mario Negri Institute for Pharmacological ResearchGiuseppe Remuzzi, MD, Principal investigator, IRCCS - istituto di Ricerche Farmacologiche Mario Negri - A.O. Papa Giovanni XXIII BGGiovanni Rota, MD, Principal investigator, A.O. Papa Giovanni XXIII, Bergamo, Italy - U.O. Chirurgia PediatricaSalvatore De Pascale, MD, Principal investigator, A.O. Papa Giovanni XXIII, Bergamo, Italy - U.O. Chirurgia PediatricaFrancesco La Canna, MD, Principal investigator, A.O. Papa Giovanni XXIII, Bergamo, Italy - U.O. Chirurgia PediatricaGiuseppe Piccolo, MD, Principal investigator, NIT (North Italian Transplant)Giuseppe Rossini, MD, Principal investigator, NIT (North Italian Transplant)Sergio Vesconi, MD, Principal investigator, NIT (North Italian Transplant)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055950
- Sponsor's protocol ID
- PREDICTION
- Acronym
- PREDICTION
- Status last verified
- Aug 2018
- First submitted
- 28 Jan 2014
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROSPECTIVE STUDY TO COMPARE EARLY GRAFT FUNCTION OF RECIPIENTS OF SINGLE OR DUAL KIDNEY ORGANS STORED IN ICE COLD SOLUTION OR PULSED PERFUSION
- ClinicalTrials.gov ID
- NCT02055950
- Acronym / sponsor ID
- PREDICTION / PREDICTION
- Conditions
- Chronic Kidney Disease
- Keywords
- Kidney transplant, Marginal donors, Pulse perfusion, Graft function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- Jul 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 5 Feb 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.
Trends in organ donor pool are characterized by an increasing age and a shift towards cerebrovascular diseases as primary causes of death. As a result, donors older than 60 years nowadays represent more than one fourth of the entire donor pool in Italy. This, along with an increasing number of patients on the waiting list for transplantation, prompted a growing use of organs from subjects older than 60 years that would have been considered unsuitable years ago. To improve graft outcomes, transplant of two older kidneys in the same recipient has been proposed. To optimize allocation of these organs to single or dual transplantation,a scoring system for kidneys, based on biopsy, with scores ranging from a minimum of 0 (indicating the absence of renal lesions) to a maximum of 12 (indicating the presence of marked changes in the renal parenchyma) has been suggested. According to this panel, kidneys with a score of 4 or lower are predicted to contain enough viable nephrons to be used as single transplants, those with a score of 5, 6, or 7 can be used as dual transplants, kidneys with a score greater than 7 are discarded. The survival of kidney grafts obtained from donors older than 60 years and allocated for single or dual transplantation on the basis of biopsy findings before transplantation was similar to that of single grafts from younger donors. To further improve these results, set-up of strategies to preserve organs is crucial to save the residual nephron mass and optimize outcomes of these marginal grafts. In this regard, over the past 30 years two methods of kidney preservation have been developed. With cold storage, the kidney is flushed once it is removed from the donor and placed in an ice-cooled container with preservation solution. With the use of pulsatile machine perfusion, the kidney is connected to a machine, which pumps a cold solution containing oxygen and nutrients through the kidney. This process allows for metabolism to continue in the kidney with end products being removed. The broad aim of the present study is to evaluate whether pulsatile machine perfusion of kidneys from older/marginal donors may provide better outcomes than static perfusion. To this purpose the outcome of recipients of perfused kidneys will be compared with the outcome of historical controls receiving non-perfused kidney selected and allocated on the basis of the same criteria and matched by gender, age and kidney histologic score.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney perfused by pulsatile machine | – | Procedure: Kidney perfused by pulsatile machine |
| Kidney stored in refrigerated solution | – | Procedure: Storage of kidney in refrigerated solution |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are eligible to receive a single or dual transplant from older/marginal deceased donors identified according to the Nord Italia Transplant criteria who consent to receive perfused with a pulsatile machine.
Key inclusion criteria (4 listed)
- Males and females aged 50 years or more and no more than 10 years older or younger than their corresponding donors;
- First single or double kidney transplant from deceased donors older than 60 years;
- Pre-implantation histologic evaluation and graft selection and allocation based on the histologic score and according to the Nord Italian Transplant (NIT) criteria;
- Written informed consent.
Key exclusion criteria (3 listed)
- Any factor that according to the NIT selection criteria represent a contraindication to receive a deceased donor kidney transplant
- Need for specific de-sensitization protocols because of high immunological risk (according to NIT criteria) or participation in other concomitant intervention studies
- Vascular abnormalities/changes that preclude the possibility to perfuse the kidney grafts by a pulsatile machine
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 |
|---|---|---|
| Storage of kidney in refrigerated solution | Procedure or surgery | Kidney stored in refrigerated solution |
| Kidney perfused by pulsatile machine | Procedure or surgery | Kidney perfused by pulsatile machine |
Primary outcome
Glomerular filtration rate (GFR)
Time frame: 6 months after transplant.
Renal resistance
Time frame: 6 hours after pulsatile machine perfusion
Renal resistance is measured by graft ultrasound. It ranges from 0 to 1.
3 secondary outcomes
Correlation between renal resistance measured at 6 hours after machine perfusion and renal histological score at pre-transplant biopsy
Time frame: 6 hours after pulsatile machine perfusion
Correlation between renal resistances measured at 6 hours after pulsatile machine perfusion and intergraft resistances measured by ultrasound at 7 days and 6 months after transplant.
Time frame: Changes from 7 days at 6 months after transplant .
Incidence of delayed graft function (DGF).
Time frame: Within the first week after transplant
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 4 Sep 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.
Paolo Cravedi, MD study chair
IRCCS - Mario Negri Institute for Pharmacological Research
Giuseppe Remuzzi, MD principal investigator
IRCCS - istituto di Ricerche Farmacologiche Mario Negri - A.O. Papa Giovanni XXIII BG
Giovanni Rota, MD principal investigator
A.O. Papa Giovanni XXIII, Bergamo, Italy - U.O. Chirurgia Pediatrica
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Mario Negri Institute for Pharmacological Research at 2 sites in Italy.
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: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Glomerular filtration rate (GFR) (time frame: 6 months after transplant.). 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 4 Sep 2018.