End Stage Renal Failure With Renal TransplantPhase 1NCT01285375
Safety and Preliminary Efficacy of the Treatment of Kidney Allografts With Curcumin-containing Preservation Solution
A Phase 1 study testing CDC solution and UW-solution in people with End Stage Renal Failure With Renal Transplant, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin complex (CDC) solution to graft perfusion solution is studied. CDC has proved safe and highly effective in preventing primary graft non-function, delayed graft function and chronic dysfunction in pre-clinical kidney transplantation… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Failure With Renal Transplant
- What is being tested?
- CDC solution and UW-solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 1
- 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
- Patients with ESRD assigned for kidney transplantation, written informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki, 00029-HUS
Kaija Salmela, Docent
Jakob Stenman, MD, PhD
About this study
The safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin complex (CDC) solution to graft perfusion solution is studied. CDC has proved safe and highly effective in preventing primary graft non-function, delayed graft function and chronic dysfunction in pre-clinical kidney transplantation animal models. The hypothesis is that addition of CDC to the graft perfusion solution will decrease the incidence of delayed graft function in human kidney transplantation subjects.
- Being tested
- CDC solution, UW-solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDC solutionDevice
Also called Curcumin-cyclodextrin
2 ml of CDC 12/mg/ml is added to 1 l of UW solution. 500 ml of of this solution is used for flushing the kidney allograft prior to transplantation
UW-solutionDevice
Also called Viaspan
500 ml of UW solution is used for flushing the kidney allograft prior to transplantation
| Study group | Role | What they receive |
|---|---|---|
| CDC graft perfusion | Active comparator | Flushing of kidney allografts prior to transplantation with UW-solution containing CDC Receives: Device: CDC solution |
| Sham perfusion | Sham comparator | Not described Receives: Device: UW-solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed Graft Function
Measured: 7 days
Secondary outcomes (6)
Primary non-function
Measured: 1 year
Acute rejection
Measured: 1 year
Graft function eGFR
Measured: 30 days, 90 days
Graft Survival
Measured: 1 year
Patient Survival
Measured: 1 year
Length of stay in hospital
Measured: upto 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure With Renal TransplantStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Academy of Finland
- Investigators
- Kaija Salmela, Docent, Principal investigator, Head of Kidney Transplantation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285375
- Sponsor's protocol ID
- 236153
- Other IDs
- 236153
- Status last verified
- Jan 2011
- First submitted
- 26 Jan 2011
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of the Treatment of Kidney Allografts With Curcumin-containing Preservation Solution
- ClinicalTrials.gov ID
- NCT01285375
- Acronym / sponsor ID
- 236153
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki, Academy of Finland
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 28 Jan 2011 (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 safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin complex (CDC) solution to graft perfusion solution is studied. CDC has proved safe and highly effective in preventing primary graft non-function, delayed graft function and chronic dysfunction in pre-clinical kidney transplantation animal models. The hypothesis is that addition of CDC to the graft perfusion solution will decrease the incidence of delayed graft function in human kidney transplantation subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDC graft perfusion | Active comparator | Device: CDC solutionFlushing of kidney allografts prior to transplantation with UW-solution containing CDC |
| Sham perfusion | Sham comparator | Device: UW-solution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ESRD assigned for kidney transplantation, written informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CDC solutionAlso: Curcumin-cyclodextrin2 ml of CDC 12/mg/ml is added to 1 l of UW solution. 500 ml of of this solution is used for flushing the kidney allograft prior to transplantation | Device | CDC graft perfusion |
| UW-solutionAlso: Viaspan500 ml of UW solution is used for flushing the kidney allograft prior to transplantation | Device | Sham perfusion |
Primary outcome
Delayed Graft Function
Time frame: 7 days
6 secondary outcomes
Primary non-function
Time frame: 1 year
Acute rejection
Time frame: 1 year
Graft function eGFR
Time frame: 30 days, 90 days
Graft Survival
Time frame: 1 year
Patient Survival
Time frame: 1 year
Length of stay in hospital
Time frame: upto 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2011.
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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.
Kaija Salmela, Docent principal investigator
Head of Kidney Transplantation Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CDC solution and UW-solution in people with End Stage Renal Failure With Renal Transplant, run by Helsinki University Central Hospital at 1 site in Finland.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2011. 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 Finland. 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. Some participants in this study may receive a placebo. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jakob Stenman, MD, PhD (+35894711, jakob.stenman@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed Graft Function (time frame: 7 days). 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 28 Jan 2011.