Kidney TransplantationNCT03134625
Metabolite Biomarkers Related to Acute Rejection in Kidney Transplantation
An observational study of Kidney Transplantation and Rejection Acute Renal, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The development of acute rejection can only be considered in cases with increasing serum creatinine in patients with kidney transplantation. However, the serum creatinine itself is not specific but also accurate for detection of acute rejection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplantation, Rejection Acute Renal
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jun 2016to 31 Jul 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population includes low or moderate risk kidney transplantation. They should have triple immunosuppression.
Who may be able to join
- Kidney transplant patients in Seoul National University Hospital
- Patients with triple maintenance immunosuppression including Tacrolimus, mycophenolate and steroid
Who cannot join
- History of other organ transplantation
- ABOi and/or crossmatch(+) transplantation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jongwon Ha, MD, PhD, +82-2-2072-2991, jwhamd@snu.ac.kr
About this study
Official title: Identification of Metabolite Biomarkers Related to Acute Rejection of Patients With Kidney Transplantation
The development of acute rejection can only be considered in cases with increasing serum creatinine in patients with kidney transplantation. However, the serum creatinine itself is not specific but also accurate for detection of acute rejection. So The specific biomarker is required for acute rejection of kidney transplant. In this study, the investigators will enroll 200 consecutive kidney transplant patients in Seoul National University Hospital and follow up. Serial collection of urine and serum will be done. Acute rejection specific urine metabolite will be found by LC MS/MS.
- Conditions
- Kidney Transplantation, Rejection Acute Renal
- Keywords
- metabolomics, biomarker, acute rejection
What is being measured
The primary outcome is the main question the study is designed to answer.
biomarker for acute rejection in kidney transplantation
urine metabolite which is specific for kidney transplant rejection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start28 Jun 2016
- Primary completion30 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134625
- Sponsor's protocol ID
- 1606-069-771
- Status last verified
- May 2022
- First submitted
- 26 Apr 2017
- Last updated
- 20 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Metabolite Biomarkers Related to Acute Rejection of Patients With Kidney Transplantation
- ClinicalTrials.gov ID
- NCT03134625
- Acronym / sponsor ID
- 1606-069-771
- Conditions
- Kidney Transplantation, Rejection Acute Renal
- Keywords
- metabolomics, biomarker, acute rejection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 1 May 2017 (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.
The development of acute rejection can only be considered in cases with increasing serum creatinine in patients with kidney transplantation. However, the serum creatinine itself is not specific but also accurate for detection of acute rejection. So The specific biomarker is required for acute rejection of kidney transplant. In this study, the investigators will enroll 200 consecutive kidney transplant patients in Seoul National University Hospital and follow up. Serial collection of urine and serum will be done. Acute rejection specific urine metabolite will be found by LC MS/MS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes low or moderate risk kidney transplantation. They should have triple immunosuppression.
Key inclusion criteria (2 listed)
- Kidney transplant patients in Seoul National University Hospital
- Patients with triple maintenance immunosuppression including Tacrolimus, mycophenolate and steroid
Key exclusion criteria (2 listed)
- History of other organ transplantation
- ABOi and/or crossmatch(+) transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
biomarker for acute rejection in kidney transplantation
Time frame: 1 year
urine metabolite which is specific for kidney transplant rejection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Rejection Acute Renal, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 2 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 20 May 2022. 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 South Korea. 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 Jongwon Ha, MD, PhD (+82-2-2072-2991, jwhamd@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomarker for acute rejection in kidney transplantation (time frame: 1 year). 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 20 May 2022.