Delayed Graft FunctionPhase 1NCT03773211
Renaparin® in Kidney Transplantation
A Phase 1 study testing Renaparin in people with Delayed Graft Function, run by Corline Biomedical AB at 3 sites in Sweden.
Trial summary
This study evaluates the safety and tolerability of Renaparin in adult patients receiving a deceased donor kidney treated ex-vivo with Renaparin prior to transplantation. Half the patient group will receive a kidney treated with Renaparin, while the other half of the patient group will receive a kidney treated with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Delayed Graft Function
- What is being tested?
- Renaparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 3 sitesSweden
- Study dates
- 14 Feb 2019to 21 Apr 2020
- 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
- Organs:
- Kidney must come from a deceased donor above 18 years of age
- The regular protocols for organ donation according to Swedish law can be followed
- Patients:
- Male and female patients 18 - 75 years of age.
- Ability to provide written informed consent.
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- Mentally stable and able to comply with the procedures of the study protocol
- Patient has been listed for kidney transplantation from a deceased donor at the clinical sites included in this study.
- Negative crossmatch test prior to transplantation and no existence of donor-specific antibodies
- Receiving first or second renal transplantation
Who cannot join
- Organs:
- Organs from donors deceased due to cardiac death.
- Organs which have not been adequately perfused during HMP, as judged by the transplantation surgeon on call.
- Patients:
- Use of an investigational drug or other investigational treatment, that could interfere with the outcome of the present trial, in the 30 days' period before Study Day 1
- Increased risk of thrombosis (ex. homozygous APC-resistance) or bleeding (INR>1.5)
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- Anticoagulant treatment with Warfarin for indication unrelated to the kidney transplantation
- History of heparin-induced thrombocytopenia (HIT)
- History of or positive for HIV, HBV, or HCV
- History of oncological malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
- Scheduled to undergo multi-organ transplantation or dual kidney transplantation
- Current drug and/or alcohol abuse
- Known fish allergy
- History or presence of a medical condition or disease or psychiatric condition that in the investigator's assessment would place the patient at an unacceptable risk for study participation
- Lactating or pregnant women or women who intend to become pregnant
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during study treatment. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly. Such methods include (in "Recommendations related to contraception and pregnancy testing in clinical trials", supplied from www.hma.eu/):
- Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation
- oral
- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation
- oral
- injectable
- implantable
- intrauterine device
- intrauterine hormone-releasing system
- bilateral tubal occlusion
- vasectomized partner
- Patients who the investigator considers not eligible to give informed consent
- Presence of ECG-based evidence of acute myocardial infarction, unstable angina, decompensated heart failure, third degree of heart block or cardiac arrhythmia associated with hemodynamic stability
- Patients with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo a kidney transplantation
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Transplantationscentrum, Sahlgrenska University Hospital
Gothenburg, 41345
Department of Transplantation Surgery, Karolinska University Hospital, Huddinge
Stockholm, 14186
Department of Surgical Sciences, Section of Transplantation Surgery, Uppsala University Hospital
Uppsala, 75185
About this study
Official title: Phase I Double Blind Placebo Controlled Safety Study of ex Vivo Treatment of Kidneys From Deceased Donors With Renaparin®, Followed by Transplantation to Study Population
This study evaluates the safety and tolerability of Renaparin in adult patients receiving a deceased donor kidney treated ex-vivo with Renaparin prior to transplantation. Half the patient group will receive a kidney treated with Renaparin, while the other half of the patient group will receive a kidney treated with placebo.
Read the detailed description
Kidney transplantation is the last resort for end-stage renal disease (ESRD). A key problem after transplantation is Delayed Graft Function (DGF). Short term, DGF will result in patients being put on dialysis in the immediate time-period after transplantation. In the longer perspective DGF is associated with increased risk of graft failure, thus decreasing the efficacy of the kidney transplantation.
Renaparin is a new product under development for the prevention of DGF in association with kidney transplantation. The product binds to the kidney vascular endothelium and its pharmacological effect is based on a local and effective presentation of heparin. Renaparin is administered ex vivo to the kidney by adding it to the preservation solution during Hypothermic Machine Perfusion (HMP) prior to transplantation.
- Conditions
- Delayed Graft Function
- Being tested
- Renaparin, Placebo
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenaparinDrug
50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation
PlaceboDrug
50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation
| Study group | Role | What they receive |
|---|---|---|
| Renaparin | Experimental | Solution administered once to kidney ex-vivo Receives: Drug: Renaparin |
| Placebo | Placebo comparator | Placebo administered once to kidney ex-vivo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number and severity grade of Serious Adverse Events and Adverse Events including description of their associated MedDRA terms during the first 30 days after transplantation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start14 Feb 2019
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Graft FunctionStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corline Biomedical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amir Sedigh, MD, Principal investigator, Section of Transplantation Surgery, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773211
- Sponsor's protocol ID
- RENAPAIR 01
- Status last verified
- Jun 2020
- First submitted
- 10 Dec 2018
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Double Blind Placebo Controlled Safety Study of ex Vivo Treatment of Kidneys From Deceased Donors With Renaparin®, Followed by Transplantation to Study Population
- ClinicalTrials.gov ID
- NCT03773211
- Acronym / sponsor ID
- RENAPAIR 01
- Conditions
- Delayed Graft Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Corline Biomedical ABIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 12 Dec 2018 (actual)
- 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.
This study evaluates the safety and tolerability of Renaparin in adult patients receiving a deceased donor kidney treated ex-vivo with Renaparin prior to transplantation. Half the patient group will receive a kidney treated with Renaparin, while the other half of the patient group will receive a kidney treated with placebo.
Detailed description
Kidney transplantation is the last resort for end-stage renal disease (ESRD). A key problem after transplantation is Delayed Graft Function (DGF). Short term, DGF will result in patients being put on dialysis in the immediate time-period after transplantation. In the longer perspective DGF is associated with increased risk of graft failure, thus decreasing the efficacy of the kidney transplantation.
Renaparin is a new product under development for the prevention of DGF in association with kidney transplantation. The product binds to the kidney vascular endothelium and its pharmacological effect is based on a local and effective presentation of heparin. Renaparin is administered ex vivo to the kidney by adding it to the preservation solution during Hypothermic Machine Perfusion (HMP) prior to transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renaparin | Experimental | Drug: RenaparinSolution administered once to kidney ex-vivo |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered once to kidney ex-vivo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Kidney must come from a deceased donor above 18 years of age
- The regular protocols for organ donation according to Swedish law can be followed
- Male and female patients 18 - 75 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol
Key exclusion criteria (31 listed)
- Organs from donors deceased due to cardiac death.
- Organs which have not been adequately perfused during HMP, as judged by the transplantation surgeon on call.
- Use of an investigational drug or other investigational treatment, that could interfere with the outcome of the present trial, in the 30 days' period before Study Day 1
- Increased risk of thrombosis (ex. homozygous APC-resistance) or bleeding (INR>1.5)
- Anticoagulant treatment with Warfarin for indication unrelated to the kidney transplantation
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 |
|---|---|---|
| Renaparin50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation | Drug | Renaparin |
| Placebo50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation | Drug | Placebo |
Primary outcome
Adverse Events
Time frame: 30 days
Number and severity grade of Serious Adverse Events and Adverse Events including description of their associated MedDRA terms during the first 30 days after 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 1 Jul 2020.
Related trials for Delayed Graft Function
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
Active, not recruitingPhase 2
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Delayed Graft Function
Not yet recruiting
Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study
Kidney Failure, Chronic, Kidney Transplantation
Recruiting
The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
Delayed Graft Function, Kidney Transplantation
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.
Amir Sedigh, MD principal investigator
Section of Transplantation Surgery, Uppsala University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Renaparin in people with Delayed Graft Function, run by Corline Biomedical AB at 3 sites in Sweden.
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 10 inclusion and 31 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 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
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?
Adverse Events (time frame: 30 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 1 Jul 2020.