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Evidence of Liver TransplantationPhase 3HRCSDBDNCT02613195

Clinical Trial of Hydrogen-Rich Celsior Solution Applied in Aging DBD Liver/Kidney Transplantation

A Phase 3 study testing Hydrogen-Rich Celsior Solution in people with Evidence of Liver Transplantation, run by RenJi Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to investigate whether hydrogen-rich Celsior solution improve the quality of aging grafts in liver/kidney transplantation. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Evidence of Liver Transplantation
What is being tested?
Hydrogen-Rich Celsior Solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesChina
Study dates
Jan 2016to Feb 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 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Donors:
  • Age of the donor ≥60 yrs.
  • The donor has no historical records of drug abuse, alcoholic abuse, homosexual,or drug addiction, etc.
  • Evaluate infections and infectious disease of the donor.
  • History of malignant tumor;
  • History of hypertension, diabetes, hemophilia, or other anticoagulant disease,kidney donor should not have a history of kidney disease.
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  • Daily urine volume is approximately normal.
  • Donor should be subjected to physical examination by medical doctor of OPO stuff before donation; the OPO stuff should realize whether the potential donor has infected lesion or not, such as abscess, ulcer, lymphadenectasis， etc., and evaluate infectious risk of recipient post-operationally.
  • OPO stuff should realize the dynamic change of body temperature, as well as various intensive care parameters of the potential donor, it shall be very important to be sure whether the potential donor has pulmonary/ systemic infections or not,especially for whom has longer ICU duration (> 7 Days).
  • The potential donor should has a systolic blood pressure ≥ 50 mm Hg (1mmHg=0.133 kPa) and arterial SaO > 80%.
  • Liver Biochemistry: alanine aminotransferase (ALT) ≤ 6ULN, total bilirubin (TBil) ≤ 50umol/L;Kidney Biochemistry: serum creatinine (sCre) ≤ 2ULN;
  • Negative anti-HIV antibody;
  • Negative bacterial and fungal culture in blood;
  • Ultrasonic diagnosis of fatty liver, trauma, hematoma, lithiasis, etc., as well as size of both kidney, hydronephrosis, nephrolithiasis, etc. if possible.
  • Graft liver should be soft, normal color and even, no tumor or other abnormity;steatosis ≤ 30% by liver biopsy.Graft kidneys should have complete renal capsule with no congestion or bleeding;proximal tubular necrosis ≤ 50%, without obvious structural damage.Organ (liver and kidney) cold ischemia time (CIT) is determined as the time duration from cold preservation of organs to transplant re-perfusion. CIT of aging DBD liver and kidney graft should be ≤ 10 and16 hours, respectively.
  • Recipients：
  • Aged between 18-65 years old
  • MELD score ≤25,BMI≤25
  • Patients with tumor,the expected lifetime≥6 months
  • Agree to anticipate the trial and sign the informed consent

Who cannot join

  • Donor's age < 60 yrs;
  • The donor has historical records of drug abuse, alcoholic abuse, homosexual, or drug addiction, etc.
  • The donor is HIV infected, or has severe infection, or positive bacterial and/ or fungal culture results;
  • Uncontrollable hypertension, diabetics;
  • Malignant tumor;
  • Unstable hemodynamic response or SaO status, such as systolic pressure <50 mm Hg (1mmHg=0.133 kPa) , or arterial SaO<80%.
  • Liver Biochemistry: alanine aminotransferase (ALT)>6ULN, total bilirubin (TBil)>50umol/L;
  • Graft liver has a steatosis >30%, or graft kidney has a proximal tubular necrosis>50% or obvious glomerular sclerosis.

Trial locations and contacts

2 sites in 1 country.

Xia Qiang, investigator contact

+86-21-68383775

xiaqiang@shsmu.edu.cn

Xue Feng, investigator contact

+8613761267573

fengxue6879@163.com

China2 sites

  • Ren Ji Hospital

    Shanghai, Shanghai Municipality, 200127

    Xia Qiang, Investigator, +86-21-68383775, xiaqiang@shsmu.edu.cn

    Xue Feng, Investigator, +8613761267573, fengxue6879@163.com

  • Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, 200127

Other trials in China

About this study

Official title: Hydrogen-Rich Celsior Solution Improve the Quality of Aging DBD Grafts in Liver/Kidney Transplantation: Prospective, Randomized Clinical Trial

The purpose of this study is to investigate whether hydrogen-rich Celsior solution improve the quality of aging grafts in liver/kidney transplantation.

Read the detailed description

The organ shortage has been rising to impede the development of organ transplantation.To find a solution, transplantation center is working on the application of marginal grafted liver or renal, especially the aging grafts. The most common inducement of organ dysfunction during the perioperation is liver/renal ischemia-reperfusion (I/R) injury, caused by the generation of cytotoxic oxygen radicals. Hydrogen gas is a kind of reducing gas, which has been reported to display antioxidant properties and protective effects against organ dysfunction induced by various I/R injuries. Investigators will investigate whether hydrogen-rich Celsior solution improve the quality of aging grafts in liver/ kidney transplantation.

Being tested
Hydrogen-Rich Celsior Solution
Keywords
Ischemia-Reperfusion Injury, oxidative stress, organ preservation, Hydrogen, Kidney Transplantation
Medical subject headings
Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydrogen-Rich Celsior SolutionDrug

    Also called HR solution

    Before the procedure, add hydrogen gas into Celsior solution. After harvesting the liver/kidney grafts, lavage and cold store the grafts with Hydrogen-Rich Celsior Solution.

Study groups in NCT02613195
Study groupRoleWhat they receive
Hydrogen-rich Celsior solutionExperimentalUsing aging liver grafts（≥60 years old)，lavaged and cold stored with hydrogen-rich Celsior solution for 2-4 hours.
Receives: Drug: Hydrogen-Rich Celsior Solution
Celsior solutionNo interventionUsing aging liver/kidney grafts（≥60 years old）, lavaged and cold stored with common Celsior solution for 2-4 hours.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Aspartate Aminotransferase(AST)/Alanine Aminotransferase(ALT)

    Measured: up to 6 months

  2. Change From Baseline in direct bilirubin(DBil)/total bilirubin(TBil)

    Measured: up to 6 months

  3. Change From Baseline in creatinine

    Measured: up to 6 months

  4. Change From Baseline in glomerular filtration rate（GFR）

    Measured: up to 6 months

Secondary outcomes (7)

  1. Pathological score of liver/kidney preservation injury during surgery

    Measured: during surgery

  2. Mitochondrial function index of hepatocyte/nephrocyte during surgery

    Measured: during surgery

  3. The total incidence of adverse events/incidence of severe adverse events

    Measured: up to 6 months

  4. postoperative complications

    Measured: up to 6 months

  5. Early graft function incidence

    Measured: baseline and 6 months

  6. Graft dysfunction incidence

    Measured: baseline and 6 months

  7. Recipient survival

    Measured: baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionFeb 2017 (estimated)
  4. Study completionFeb 2017 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02613195
Sponsor's protocol ID
RenJiH-20151020
Acronym
HRCSDBD
Status last verified
Oct 2015
First submitted
24 Oct 2015
Last updated
24 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Abe T, Li XK, Yazawa K, Hatayama N, Xie L, Sato B, Kakuta Y, Tsutahara K, Okumi M, Tsuda H, Kaimori JY, Isaka Y, Natori M, Takahara S, Nonomura N. Hydrogen-rich University of Wisconsin solution attenuates renal cold ischemia-reperfusion injury. Transplantation. 2012 Jul 15;94(1):14-21. doi: 10.1097/TP.0b013e318255f8be.

    PubMed 22683850

  • Qian L, Shen J. Hydrogen therapy may be an effective and specific novel treatment for acute graft-versus-host disease (GVHD). J Cell Mol Med. 2013 Aug;17(8):1059-63. doi: 10.1111/jcmm.12081. Epub 2013 Jun 7.

    PubMed 23742028

  • Buchholz BM, Masutani K, Kawamura T, Peng X, Toyoda Y, Billiar TR, Bauer AJ, Nakao A. Hydrogen-enriched preservation protects the isogeneic intestinal graft and amends recipient gastric function during transplantation. Transplantation. 2011 Nov 15;92(9):985-92. doi: 10.1097/TP.0b013e318230159d.

    PubMed 21956195

  • Liu Y, Yang L, Tao K, Vizcaychipi MP, Lloyd DM, Sun X, Irwin MG, Ma D, Yu W. Protective effects of hydrogen enriched saline on liver ischemia reperfusion injury by reducing oxidative stress and HMGB1 release. BMC Gastroenterol. 2014 Jan 12;14:12. doi: 10.1186/1471-230X-14-12.

    PubMed 24410860

  • Noda K, Shigemura N, Tanaka Y, Bhama J, D'Cunha J, Kobayashi H, Luketich JD, Bermudez CA. Hydrogen preconditioning during ex vivo lung perfusion improves the quality of lung grafts in rats. Transplantation. 2014 Sep 15;98(5):499-506. doi: 10.1097/TP.0000000000000254.

    PubMed 25121557

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hydrogen-Rich Celsior Solution in people with Evidence of Liver Transplantation, run by RenJi Hospital at 2 sites in China.

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 20 inclusion and 8 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 24 Nov 2015. 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 China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xia Qiang, investigator (+86-21-68383775, xiaqiang@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Aspartate Aminotransferase(AST)/Alanine Aminotransferase(ALT) (time frame: up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02613195, which also lists 5 linked publications.

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 24 Nov 2015.

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