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Delayed Graft FunctionXi'anCriNCT02876692

Prediction and Management of Delayed Graft Function Based on Donor Criteria and LifePort Platform

An observational study of Delayed Graft Function, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a prospective cohort study: 1. First step: to establish a new scoring system for predication of delayed graft function(DGF) following kidney transplantation based on previous and new study data. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Delayed Graft Function
What is being tested?
Machine perfusion
Type of treatment
Medical device
How many people
1,000 participants
Where
1 siteChina
Study dates
Jan 2016to Dec 2019
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients assigned the deceased donor kidney to transplant in the waiting list.

Who may be able to join

  • Donor
  • 1. Comply with the national donation after citizen death guideline
  • 2. No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
  • 3. No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
  • 4. No activity of untreated systemic bacterial, viral or fungal infection;
  • 5. Patients definitely identified
Show all 12Show fewer
  • Recipient:
  • 1. 65 y old ≥Age> = 18 years old, male or female
  • 2. BMI<26
  • 3. Renal transplantation first time
  • 4. Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
  • 5. Before the clinical trial, Patient sign informed consent voluntarily

Who cannot join

  • Donor
  • 1. Older than 65 years old
  • 2.Serum hepatitis B virus (HBV), hepatitis C virus (HCV), HIV positive
  • 3.Donor kidney cold storage time over 30 hours
  • 4.Warm ischemia time over 20 minutes
  • 5.Other reagents are added perfusion for regulation of donor renal function
Show all 10Show fewer
  • Recipient:
  • 1.Involved in other study.
  • 2.Double organ or multi-organ transplant
  • 3.A,B,O blood type-incompatible

Trial locations and contacts

1 site in 1 country.

Chenguang D Ding, PhD contact

8602985323721

doctor_ding@126.com

Xiaoming D Ding, PhD contact

8602985323721

xmding@mail.xju.edu.cn

China1 site, 1 recruiting

  • First Affiliated Hospital Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

    Chenguang Ding, PhD, doctor_ding@126.com

    Recruiting

Other trials in China

About this study

This is a prospective cohort study:

  1. First step: to establish a new scoring system for predication of delayed graft function(DGF) following kidney transplantation based on previous and new study data. The new scoring system is comprised of two parts: Xi'an Criteria of donor scoring system and kidney evaluation System based on Lifeport platform ).
  2. Second step: validate the new scoring system through prospective cohort study in our transplantation center and modify the scoring system if needed. Recruiting 300 patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF,primary non-function (PNF), acute rejection (AR), graft survival and patient survival
  3. Step 3: Further validate the new scoring system in six other transplantation centers and developing a software in the end. Recruiting 300 patients, follow up at day 3, week 1, month 1, month 3, month 6 and month 12. Patients will be followed for Cr30cl, DGF, PGF, AR, graft survival and patient survival
Read the detailed description

Subjects are enrolled to collect the data of donors and recipients. Investigators also collect the data of recipients or donated organs as following: physiological and biochemical indexes, machine perfusion parameters, and the other factors effected on renal transplant outcomes. A Cox proportional hazards model and multiple linear regression analysis will be applied to examine the correlation among the univariate and multivariate. Based on the above analysis to improve the new scoring system, Lifeport work platform evaluation system and donor kidney quality evaluation system. Then, a multi-center clinical trial will be started to improve and verify the new scoring system. Finally, a donor kidney evaluation APP will be developed based on the scoring system and the database of clinical trials. An applicaiotion (APP) will be popularized the national transplant surgeons.

Being tested
Machine perfusion
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.

  • Machine perfusionDevice

    Deceased donor kidneys were preserved by hypothermic machine perfusion

What is being measured

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

  1. delayed graft function

    Measured: 7 days after renal transplant

  2. Transplant nephrectomy

    Measured: 1 year after reanl transplant

Secondary outcomes (4)

  1. Abnormal serum creatinine

    Measured: Serum creatinine did not return to the normal range within the first 30 days

  2. Renal dysfunction caused by the acute rejection

    Measured: within the first 3 months

  3. lung infection lead to death

    Measured: within the first 1 year

  4. Renal dysfunction caused by Surgical complications

    Measured: within the first 3 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 Aug 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02876692
Sponsor's protocol ID
XAC-01
Acronym
Xi'anCri
Status last verified
Aug 2016
First submitted
19 Aug 2016
Last updated
1 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Allen AM, Kim WR, Xiong H, Liu J, Stock PG, Lake JR, Chinnakotla S, Snyder JJ, Israni AK, Kasiske BL. Survival of recipients of livers from donation after circulatory death who are relisted and undergo retransplant for graft failure. Am J Transplant. 2014 May;14(5):1120-8. doi: 10.1111/ajt.12700. Epub 2014 Apr 14.

    PubMed 24731165

  • Huang J, Millis JM, Mao Y, Millis MA, Sang X, Zhong S. A pilot programme of organ donation after cardiac death in China. Lancet. 2012 Mar 3;379(9818):862-5. doi: 10.1016/S0140-6736(11)61086-6. Epub 2011 Nov 10.

    PubMed 22078722

  • Huang J, Wang H, Fan ST, Zhao B, Zhang Z, Hao L, Huo F, Liu Y. The national program for deceased organ donation in China. Transplantation. 2013 Jul 15;96(1):5-9. doi: 10.1097/TP.0b013e3182985491.

    PubMed 23743728

  • World Health Organization. WHO guiding principles on human cell, tissue and organ transplantation. Transplantation. 2010 Aug 15;90(3):229-33. doi: 10.1097/TP.0b013e3181ec29f0. No abstract available.

    PubMed 20664493

  • Moers C, Leuvenink HG, Ploeg RJ. Non-heart beating organ donation: overview and future perspectives. Transpl Int. 2007 Jul;20(7):567-75. doi: 10.1111/j.1432-2277.2007.00455.x. Epub 2007 Jan 30.

    PubMed 17263786

  • Kokkinos C, Antcliffe D, Nanidis T, Darzi AW, Tekkis P, Papalois V. Outcome of kidney transplantation from nonheart-beating versus heart-beating cadaveric donors. Transplantation. 2007 May 15;83(9):1193-9. doi: 10.1097/01.tp.0000261710.53848.51.

    PubMed 17496535

  • Jochmans I, Darius T, Kuypers D, Monbaliu D, Goffin E, Mourad M, Ledinh H, Weekers L, Peeters P, Randon C, Bosmans JL, Roeyen G, Abramowicz D, Hoang AD, De Pauw L, Rahmel A, Squifflet JP, Pirenne J. Kidney donation after circulatory death in a country with a high number of brain dead donors: 10-year experience in Belgium. Transpl Int. 2012 Aug;25(8):857-66. doi: 10.1111/j.1432-2277.2012.01510.x. Epub 2012 Jun 13.

    PubMed 22694305

  • Chamorro C, Falcon JA, Michelena JC. Controversial points in organ donor management. Transplant Proc. 2009 Oct;41(8):3473-5. doi: 10.1016/j.transproceed.2009.09.004.

    PubMed 19857774

  • Gelb AW, Robertson KM. Anaesthetic management of the brain dead for organ donation. Can J Anaesth. 1990 Oct;37(7):806-12. doi: 10.1007/BF03006543.

    PubMed 2225301

  • Xue W, Tian P, Ding X, Pan X, Yan H, Hou J, Feng X, Xiang H, Tian X, Ren L, Zheng J, Li S. Clinical research and social status investigation for donor and recipient of living-related kidney transplant. Int Urol Nephrol. 2013 Feb;45(1):239-49. doi: 10.1007/s11255-012-0259-0. Epub 2012 Aug 15.

    PubMed 22893495

  • Wadei HM, Heckman MG, Rawal B, Taner CB, Farahat W, Nur L, Mai ML, Prendergast M, Gonwa TA. Comparison of kidney function between donation after cardiac death and donation after brain death kidney transplantation. Transplantation. 2013 Aug 15;96(3):274-81. doi: 10.1097/TP.0b013e31829807d1.

    PubMed 23778649

  • Singh RP, Farney AC, Rogers J, Zuckerman J, Reeves-Daniel A, Hartmann E, Iskandar S, Adams P, Stratta RJ. Kidney transplantation from donation after cardiac death donors: lack of impact of delayed graft function on post-transplant outcomes. Clin Transplant. 2011 Mar-Apr;25(2):255-64. doi: 10.1111/j.1399-0012.2010.01241.x.

    PubMed 20331689

  • Mallon DH, Summers DM, Bradley JA, Pettigrew GJ. Defining delayed graft function after renal transplantation: simplest is best. Transplantation. 2013 Nov 27;96(10):885-9. doi: 10.1097/TP.0b013e3182a19348.

    PubMed 24056620

  • Nagaraja P, Roberts GW, Stephens M, Horvath S, Fialova J, Chavez R, Asderakis A, Kaposztas Z. Influence of delayed graft function and acute rejection on outcomes after kidney transplantation from donors after cardiac death. Transplantation. 2012 Dec 27;94(12):1218-23. doi: 10.1097/TP.0b013e3182708e30.

    PubMed 23154212

  • Lodhi SA, Lamb KE, Uddin I, Meier-Kriesche HU. Pulsatile pump decreases risk of delayed graft function in kidneys donated after cardiac death. Am J Transplant. 2012 Oct;12(10):2774-80. doi: 10.1111/j.1600-6143.2012.04179.x. Epub 2012 Jul 23.

    PubMed 22823748

Questions about this trial

What is this clinical trial studying?

An observational study of Delayed Graft Function, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site 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 12 inclusion and 10 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 1 Sep 2016. 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 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.

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 Chenguang D Ding, PhD (8602985323721, doctor_ding@126.com), 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 after renal 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?

On the ClinicalTrials.gov record for NCT02876692, which also lists 15 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 1 Sep 2016.

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