Delayed Function of Renal TransplantCIHMPNCT02621281
Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients
A study testing Kidney Transporter machines and cold storage in people with Delayed Function of Renal Transplant, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This is a multi-centers prospective, randomized, controlled trial. This trial will investigate the clinical outcome of kidney transplant recipients whose kidneys are under two different forms of organ preservation--hypothermic machine perfusion vs. static cold storage. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Delayed Function of Renal Transplant
- What is being tested?
- Kidney Transporter machines and cold storage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Jan 2019
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Donor
- Comply with the national DCD（donor after citizen death) guideline
- No high risk activities: such as history of drug abuse, history of intravenous drug use and risky sexual behavior
- No malignant melanoma, metastatic cancer, or incurable cancer; some of the early stages of cancer after a successful treatment can also be considered
- No active, untreated systemic bacterial, viral or fungal infection;
- Patients definitely identified
Show all 13Show fewer
- Mechanical perfusion RI (resistance index ) [0.18, 0.50]
- Recipient:
- Age> = 16 years old, male or female
- BMI<28
- First Renal transplantation
- Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
- Before the clinical trial, Patient sign informed consent voluntarily
Who cannot join
- Donor
- Older than 50 years old
- Serum HBV (hepatitis B virus), HCV (hepatitis C virus), HIV positive
- Donor kidney cold storage time over 30 hours
- Warm ischemia time over 20 minutes
- Other reagents are added perfusion for regulation of donor renal function
Show all 10Show fewer
- Recipient:
- Double organ or multi-organ transplant
- Blood type-incompatible
- Patients with other malignant diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Chenguang Ding, PhD, doctor_ding@126.com
About this study
This is a multi-centers prospective, randomized, controlled trial. This trial will investigate the clinical outcome of kidney transplant recipients whose kidneys are under two different forms of organ preservation--hypothermic machine perfusion vs. static cold storage. Factors during the machine perfusion, such as the pressure, flow rate, and resistance index will also be investigated.
Read the detailed description
In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. All 400 patients will be followed for 1 year. The primary endpoint is delayed graft function (requiring dialysis in the first week after transplantation) and duration of delayed graft function. The second endpoints: GFR at week 1, month3, month6 and month 12 post-transplant.
- Conditions
- Delayed Function of Renal Transplant
- Being tested
- Kidney Transporter machines, cold storage
- Keywords
- hypothermic machine perfusion, Kidney Transplantation, Delayed graft function, perfusion pressure
- 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.
Kidney Transporter machinesDevice
Kidney Transporter gently pumps the special cold solution through the kidney which outside the body.
cold storageDevice
The kidneys procurement from the donor will be cold stored using some cold preservation solution.
| Study group | Role | What they receive |
|---|---|---|
| cold storage | Active comparator | In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration. Receives: Device: cold storage |
| Kidney Transporter machines | Active comparator | In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration. Receives: Device: Kidney Transporter machines |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Delayed graft function
Delayed graft function (DGF) is a common complication of renal transplantation. DGF can be diagnosed according to the three aspects below.
- Need for postoperative dialysis: Need for dialysis in the first week after transplant once hyperacute rejection, vascular and urinary tract complications and hyperkalemia are ruled out. ii. Urine output and serum creatinine: 1) Rise in serum Cr at 6-8 h post-operatively or <300 ml of urine despite adequate volume and diuretics. 2) Urine output <1 L in 24 h and <25% fall in serum creatinine from baseline in first 24 h post-transplant. 3) Urine output <75 mL/h in first 48 h or failure of serum Cr to decrease by 10% in the first 48 h. 4) Serum creatinine increases or remains unchanged or decreases <10%/day during 3 consecutive days postoperatively. 5) Serum creatinine >2.5mg/dL on Day 7 or need for post-transplant hemodialysis.6) Time required for the kidney to reach CrCl>10 mL/min greater than 1 week.
Measured: the first week after transplant
Secondary outcomes (1)
Estimated Glomerular Filtration Rate
Glomerular filtration rate (GFR) is the volume of fluid filtered from the renal (kidney) glomerular capillaries into the Bowman's capsule per unit time.[3] Central to the physiologic maintenance of GFR is the differential basal tone of the afferent and efferent arterioles (see diagram). In other words, the filtration rate is dependent on the difference between the higher blood pressure created by vasoconstriction of the input or afferent arteriole versus the lower blood pressure created lesser vasoconstriction of the output or efferent arteriole.
Measured: 1 week, three months, six months, 12 months after kidney transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Delayed Function of Renal TransplantStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Jilin University, 303rd Hospital of the People's Liberation Army, Fuzhou General Hospital
- Responsible party
- Principal investigator, Ding,Chenguang, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Wujun Xue, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621281
- Sponsor's protocol ID
- LPT-G-1501
- Acronym
- CIHMP
- Status last verified
- May 2017
- First submitted
- 29 Nov 2015
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moers C, Smits JM, Maathuis MH, Treckmann J, van Gelder F, Napieralski BP, van Kasterop-Kutz M, van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Paul A, Pirenne J, Ploeg RJ. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2009 Jan 1;360(1):7-19. doi: 10.1056/NEJMoa0802289.
PubMed 19118301Moers C, Pirenne J, Paul A, Ploeg RJ; Machine Preservation Trial Study Group. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2012 Feb 23;366(8):770-1. doi: 10.1056/NEJMc1111038. No abstract available.
PubMed 22356343Tapiawala SN, Tinckam KJ, Cardella CJ, Schiff J, Cattran DC, Cole EH, Kim SJ. Delayed graft function and the risk for death with a functioning graft. J Am Soc Nephrol. 2010 Jan;21(1):153-61. doi: 10.1681/ASN.2009040412. Epub 2009 Oct 29.
PubMed 19875806Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. doi: 10.1016/S0140-6736(04)17406-0.
PubMed 15541456Yarlagadda SG, Coca SG, Formica RN Jr, Poggio ED, Parikh CR. Association between delayed graft function and allograft and patient survival: a systematic review and meta-analysis. Nephrol Dial Transplant. 2009 Mar;24(3):1039-47. doi: 10.1093/ndt/gfn667. Epub 2008 Dec 22.
PubMed 19103734Jochmans I, Moers C, Smits JM, Leuvenink HG, Treckmann J, Paul A, Rahmel A, Squifflet JP, van Heurn E, Monbaliu D, Ploeg RJ, Pirenne J. Machine perfusion versus cold storage for the preservation of kidneys donated after cardiac death: a multicenter, randomized, controlled trial. Ann Surg. 2010 Nov;252(5):756-64. doi: 10.1097/SLA.0b013e3181ffc256.
PubMed 21037431Treckmann J, Moers C, Smits JM, Gallinat A, Maathuis MH, van Kasterop-Kutz M, Jochmans I, Homan van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Pirenne J, Ploeg RJ, Paul A. Machine perfusion versus cold storage for preservation of kidneys from expanded criteria donors after brain death. Transpl Int. 2011 Jun;24(6):548-54. doi: 10.1111/j.1432-2277.2011.01232.x. Epub 2011 Feb 17.
PubMed 21332580Patel SK, Pankewycz OG, Nader ND, Zachariah M, Kohli R, Laftavi MR. Prognostic utility of hypothermic machine perfusion in deceased donor renal transplantation. Transplant Proc. 2012 Sep;44(7):2207-12. doi: 10.1016/j.transproceed.2012.07.129.
PubMed 22974956Jochmans I, Moers C, Smits JM, Leuvenink HG, Treckmann J, Paul A, Rahmel A, Squifflet JP, van Heurn E, Monbaliu D, Ploeg RJ, Pirenne J. The prognostic value of renal resistance during hypothermic machine perfusion of deceased donor kidneys. Am J Transplant. 2011 Oct;11(10):2214-20. doi: 10.1111/j.1600-6143.2011.03685.x. Epub 2011 Aug 11.
PubMed 21834917Doorschodt BM, Schreinemachers MC, Behbahani M, Florquin S, Weis J, Staat M, Tolba RH. Hypothermic machine perfusion of kidney grafts: which pressure is preferred? Ann Biomed Eng. 2011 Mar;39(3):1051-9. doi: 10.1007/s10439-010-0228-7. Epub 2010 Dec 16.
PubMed 21161683Patel SK, Pankewycz OG, Weber-Shrikant E, Zachariah M, Kohli R, Nader ND, Laftavi MR. Effect of increased pressure during pulsatile pump perfusion of deceased donor kidneys in transplantation. Transplant Proc. 2012 Sep;44(7):2202-6. doi: 10.1016/j.transproceed.2012.07.109.
PubMed 22974955Sung RS, Christensen LL, Leichtman AB, Greenstein SM, Distant DA, Wynn JJ, Stegall MD, Delmonico FL, Port FK. Determinants of discard of expanded criteria donor kidneys: impact of biopsy and machine perfusion. Am J Transplant. 2008 Apr;8(4):783-92. doi: 10.1111/j.1600-6143.2008.02157.x. Epub 2008 Feb 19.
PubMed 18294347Cantafio AW, Dick AA, Halldorson JB, Bakthavatsalam R, Reyes JD, Perkins JD. Risk stratification of kidneys from donation after cardiac death donors and the utility of machine perfusion. Clin Transplant. 2011 Sep-Oct;25(5):E530-40. doi: 10.1111/j.1399-0012.2011.01477.x. Epub 2011 May 18.
PubMed 21585547Akoh JA. Kidney donation after cardiac death. World J Nephrol. 2012 Jun 6;1(3):79-91. doi: 10.5527/wjn.v1.i3.79.
PubMed 24175245Chapal M, Le Borgne F, Legendre C, Kreis H, Mourad G, Garrigue V, Morelon E, Buron F, Rostaing L, Kamar N, Kessler M, Ladriere M, Soulillou JP, Launay K, Daguin P, Offredo L, Giral M, Foucher Y. A useful scoring system for the prediction and management of delayed graft function following kidney transplantation from cadaveric donors. Kidney Int. 2014 Dec;86(6):1130-9. doi: 10.1038/ki.2014.188. Epub 2014 Jun 4.
PubMed 24897036
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Hypothermic Machine Perfusion in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT02621281
- Acronym / sponsor ID
- CIHMP / LPT-G-1501
- Conditions
- Delayed Function of Renal Transplant
- Keywords
- hypothermic machine perfusion, Kidney Transplantation, Delayed graft function, perfusion pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- The First Hospital of Jilin University, 303rd Hospital of the People's Liberation Army, Fuzhou General Hospital
- Study start
- Dec 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 3 Dec 2015 (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.
This is a multi-centers prospective, randomized, controlled trial. This trial will investigate the clinical outcome of kidney transplant recipients whose kidneys are under two different forms of organ preservation--hypothermic machine perfusion vs. static cold storage. Factors during the machine perfusion, such as the pressure, flow rate, and resistance index will also be investigated.
Detailed description
In this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. All 400 patients will be followed for 1 year. The primary endpoint is delayed graft function (requiring dialysis in the first week after transplantation) and duration of delayed graft function. The second endpoints: GFR at week 1, month3, month6 and month 12 post-transplant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold storage | Active comparator | Device: cold storageIn this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration. |
| Kidney Transporter machines | Active comparator | Device: Kidney Transporter machinesIn this randomized clinical trial, 200 kidney pairs from deceased donors will be included in the study, which will be randomly assigned, one kidney to machine perfusion and the other to cold storage. In machine perfusion group, patients will be analyzed by two subgroups based on pressure, resistance index and perfusion time duration. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Donor
- Age> = 16 years old, male or female
- BMI<28
- First Renal transplantation
- Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnant during treatment.
Key exclusion criteria (10 listed)
- Donor
- Double organ or multi-organ transplant
- Blood type-incompatible
- Patients with other malignant diseases
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 |
|---|---|---|
| Kidney Transporter machinesKidney Transporter gently pumps the special cold solution through the kidney which outside the body. | Device | Kidney Transporter machines |
| cold storageThe kidneys procurement from the donor will be cold stored using some cold preservation solution. | Device | cold storage |
Primary outcome
The rate of Delayed graft function
Time frame: the first week after transplant
Delayed graft function (DGF) is a common complication of renal transplantation. DGF can be diagnosed according to the three aspects below. i. Need for postoperative dialysis: Need for dialysis in the first week after transplant once hyperacute rejection, vascular and urinary tract complications and hyperkalemia are ruled out. ii. Urine output and serum creatinine: 1) Rise in serum Cr at 6-8 h post-operatively or <300 ml of urine despite adequate volume and diuretics. 2) Urine output <1 L in 24 h and <25% fall in serum creatinine from baseline in first 24 h post-transplant. 3) Urine output <75 mL/h in first 48 h or failure of serum Cr to decrease by 10% in the first 48 h. 4) Serum creatinine increases or remains unchanged or decreases <10%/day during 3 consecutive days postoperatively. 5) Serum creatinine >2.5mg/dL on Day 7 or need for post-transplant hemodialysis.6) Time required for the kidney to reach CrCl>10 mL/min greater than 1 week.
1 secondary outcome
Estimated Glomerular Filtration Rate
Time frame: 1 week, three months, six months, 12 months after kidney transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Results publication: PubMed 19118301Moers C, Smits JM, Maathuis MH, Treckmann J, van Gelder F, Napieralski BP, van Kasterop-Kutz M, van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Paul A, Pirenne J, Ploeg RJ. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2009 Jan 1;360(1):7-19. doi: 10.1056/NEJMoa0802289.
- Results publication: PubMed 22356343Moers C, Pirenne J, Paul A, Ploeg RJ; Machine Preservation Trial Study Group. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med. 2012 Feb 23;366(8):770-1. doi: 10.1056/NEJMc1111038. No abstract available.
- Results publication: PubMed 19875806Tapiawala SN, Tinckam KJ, Cardella CJ, Schiff J, Cattran DC, Cole EH, Kim SJ. Delayed graft function and the risk for death with a functioning graft. J Am Soc Nephrol. 2010 Jan;21(1):153-61. doi: 10.1681/ASN.2009040412. Epub 2009 Oct 29.
- Results publication: PubMed 15541456Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet. 2004 Nov 13-19;364(9447):1814-27. doi: 10.1016/S0140-6736(04)17406-0.
- Results publication: PubMed 19103734Yarlagadda SG, Coca SG, Formica RN Jr, Poggio ED, Parikh CR. Association between delayed graft function and allograft and patient survival: a systematic review and meta-analysis. Nephrol Dial Transplant. 2009 Mar;24(3):1039-47. doi: 10.1093/ndt/gfn667. Epub 2008 Dec 22.
- Results publication: PubMed 21037431Jochmans I, Moers C, Smits JM, Leuvenink HG, Treckmann J, Paul A, Rahmel A, Squifflet JP, van Heurn E, Monbaliu D, Ploeg RJ, Pirenne J. Machine perfusion versus cold storage for the preservation of kidneys donated after cardiac death: a multicenter, randomized, controlled trial. Ann Surg. 2010 Nov;252(5):756-64. doi: 10.1097/SLA.0b013e3181ffc256.
- Results publication: PubMed 21332580Treckmann J, Moers C, Smits JM, Gallinat A, Maathuis MH, van Kasterop-Kutz M, Jochmans I, Homan van der Heide JJ, Squifflet JP, van Heurn E, Kirste GR, Rahmel A, Leuvenink HG, Pirenne J, Ploeg RJ, Paul A. Machine perfusion versus cold storage for preservation of kidneys from expanded criteria donors after brain death. Transpl Int. 2011 Jun;24(6):548-54. doi: 10.1111/j.1432-2277.2011.01232.x. Epub 2011 Feb 17.
- Results publication: PubMed 22974956Patel SK, Pankewycz OG, Nader ND, Zachariah M, Kohli R, Laftavi MR. Prognostic utility of hypothermic machine perfusion in deceased donor renal transplantation. Transplant Proc. 2012 Sep;44(7):2207-12. doi: 10.1016/j.transproceed.2012.07.129.
- Results publication: PubMed 21834917Jochmans I, Moers C, Smits JM, Leuvenink HG, Treckmann J, Paul A, Rahmel A, Squifflet JP, van Heurn E, Monbaliu D, Ploeg RJ, Pirenne J. The prognostic value of renal resistance during hypothermic machine perfusion of deceased donor kidneys. Am J Transplant. 2011 Oct;11(10):2214-20. doi: 10.1111/j.1600-6143.2011.03685.x. Epub 2011 Aug 11.
- Results publication: PubMed 21161683Doorschodt BM, Schreinemachers MC, Behbahani M, Florquin S, Weis J, Staat M, Tolba RH. Hypothermic machine perfusion of kidney grafts: which pressure is preferred? Ann Biomed Eng. 2011 Mar;39(3):1051-9. doi: 10.1007/s10439-010-0228-7. Epub 2010 Dec 16.
- Results publication: PubMed 22974955Patel SK, Pankewycz OG, Weber-Shrikant E, Zachariah M, Kohli R, Nader ND, Laftavi MR. Effect of increased pressure during pulsatile pump perfusion of deceased donor kidneys in transplantation. Transplant Proc. 2012 Sep;44(7):2202-6. doi: 10.1016/j.transproceed.2012.07.109.
- Results publication: PubMed 18294347Sung RS, Christensen LL, Leichtman AB, Greenstein SM, Distant DA, Wynn JJ, Stegall MD, Delmonico FL, Port FK. Determinants of discard of expanded criteria donor kidneys: impact of biopsy and machine perfusion. Am J Transplant. 2008 Apr;8(4):783-92. doi: 10.1111/j.1600-6143.2008.02157.x. Epub 2008 Feb 19.
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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.
Wujun Xue, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kidney Transporter machines and cold storage in people with Delayed Function of Renal Transplant, 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 13 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 15 May 2017. 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 Ding, PhD (+8615091152077, doctor_ding@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of Delayed graft function (time frame: the first week after transplant). 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 NCT02621281, which also lists 18 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 15 May 2017.