Renal Transplant RejectionNCT03140514
Urine CXCL10 Chemokine Monitoring Post-renal Transplant
A study testing Rejection treatment according to clinical standard-of-care in people with Renal Transplant Rejection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
In this study investigators will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Rejection
- What is being tested?
- Rejection treatment according to clinical standard-of-care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Sep 2017to 15 Jul 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consenting adult (age>=18) renal allograft recipients
Who cannot join
- Human Leucocyte Antigen (HLA) -identical living donor transplantation
- Primary non-function
- Participation in immunosuppression interventional trials
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Transplantation Immunology & Nephrology
Basel, 4031
About this study
In this study investigators will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.
- Conditions
- Renal Transplant Rejection
- Being tested
- Rejection treatment according to clinical standard-of-care
- Keywords
- Urine chemokine monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rejection treatment according to clinical standard-of-careDrug
Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Urine CXCL10-chemokine levels will be monitored at specific time points post-transplant. Sustained elevated levels will trigger performance of a renal allograft biopsy. Any rejection will be treated. Rejection treatment according to clinical standard-of-care Receives: Drug: Rejection treatment according to clinical standard-of-care |
| Control | No intervention | Urine CXCL10-chemokine levels will be monitored at specific time points post-transplant, but the values are concealed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft loss not due to death of the patient
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
Measured: First year post-transplant
Biopsy-proven clinical acute rejection
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
Measured: 4-weeks up to 1-year post-transplant
Subclinical T-cell mediated rejection in 1-year surveillance biopsy defined by t>0 and/or v>0
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
Measured: First year post-transplant
Interstitial fibrosis / tubular atrophy with inflammation (IFTA+i defined by the Mayo Clinic criteria) in 1-year surveillance biopsy
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
Measured: First year post-transplant
Secondary outcomes (12)
Efficacy assessed by microvascular inflammation at 1-year (ptc, g, c4d, cg)
Microvascular inflammation at 1-year (ptc, g, c4d, cg)
Measured: First year post-transplant
Efficacy assessed by development of IFTA from implantation to 1-year (∆ ci, ct, cv)
Development of IFTA from implantation to 1-year (∆ ci, ct, cv)
Measured: First year post-transplant
Efficacy assessed by number of days from transplantation to biopsy-proven clinical acute rejection
number of days from transplantation to biopsy-proven clinical acute rejection
Measured: First year post-transplant
Efficacy assessed by Proteinuria >500mg/day at 6- and 12-months post-transplant
Proteinuria >500mg/day at 6- and 12-months post-transplant
Measured: First year post-transplant
Safety assessed by total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant
total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant
Measured: First year post-transplant
Safety assessed by biopsy-related complications within the first year post-transplant
biopsy-related complications within the first year post-transplant biopsy-related complications within the first year post-transplant
Measured: First year post-transplant
Safety assessed by immunosuppression-related complications as infections and cancer within the first year post-transplant
immunosuppression-related complications as infections and cancer within the first year post-transplant
Measured: First year post-transplant
Graft and its cause
Long-term outcome Graft and its cause
Measured: yearly up to 10 years
Death and its cause
Long-term outcome Death and its cause
Measured: yearly up to 10 years
Allograft function measured by creatinine and eGFR
Long-term outcome Allograft function measured by creatinine and epidermal growth factor receptor (eGFR)
Measured: yearly up to 10 years
Proteinuria
Long-term outcome Proteinuria
Measured: yearly up to 10 years
Biopsy-proven rejection
Long-term outcome Biopsy-proven rejection
Measured: yearly up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start28 Sep 2017
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant RejectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Schaub, MD, MSc, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140514
- Sponsor's protocol ID
- Urine chemokine monitoring
- Status last verified
- Aug 2022
- First submitted
- 2 May 2017
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hirt-Minkowski P, Handschin J, Stampf S, Hopfer H, Menter T, Senn L, Honger G, Wehmeier C, Amico P, Steiger J, Koller M, Dickenmann M, Schaub S. Randomized Trial to Assess the Clinical Utility of Renal Allograft Monitoring by Urine CXCL10 Chemokine. J Am Soc Nephrol. 2023 Aug 1;34(8):1456-1469. doi: 10.1681/ASN.0000000000000160. Epub 2023 May 25.
PubMed 37228005
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine CXCL10 Chemokine Monitoring Post-renal Transplant
- ClinicalTrials.gov ID
- NCT03140514
- Acronym / sponsor ID
- Urine chemokine monitoring
- Conditions
- Renal Transplant Rejection
- Keywords
- Urine chemokine monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 4 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.
In this study investigators will investigate whether early treatment of allograft rejection, as detected by urine CXCL10-monitoring, improves outcomes in renal allograft recipients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Rejection treatment according to clinical standard-of-careUrine CXCL10-chemokine levels will be monitored at specific time points post-transplant. Sustained elevated levels will trigger performance of a renal allograft biopsy. Any rejection will be treated. Rejection treatment according to clinical standard-of-care |
| Control | No intervention | –Urine CXCL10-chemokine levels will be monitored at specific time points post-transplant, but the values are concealed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consenting adult (age>=18) renal allograft recipients
Key exclusion criteria (3 listed)
- Human Leucocyte Antigen (HLA) -identical living donor transplantation
- Primary non-function
- Participation in immunosuppression interventional trials
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 |
|---|---|---|
| Rejection treatment according to clinical standard-of-careStandard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection | Drug | Intervention |
Primary outcome
Graft loss not due to death of the patient
Time frame: First year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
Biopsy-proven clinical acute rejection
Time frame: 4-weeks up to 1-year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
Subclinical T-cell mediated rejection in 1-year surveillance biopsy defined by t>0 and/or v>0
Time frame: First year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
Interstitial fibrosis / tubular atrophy with inflammation (IFTA+i defined by the Mayo Clinic criteria) in 1-year surveillance biopsy
Time frame: First year post-transplant
1-year composite outcome consisting of at least one of the primary outcomes 1 to 4
12 secondary outcomes
Efficacy assessed by microvascular inflammation at 1-year (ptc, g, c4d, cg)
Time frame: First year post-transplant
Efficacy assessed by development of IFTA from implantation to 1-year (∆ ci, ct, cv)
Time frame: First year post-transplant
Efficacy assessed by number of days from transplantation to biopsy-proven clinical acute rejection
Time frame: First year post-transplant
Efficacy assessed by Proteinuria >500mg/day at 6- and 12-months post-transplant
Time frame: First year post-transplant
Safety assessed by total number of biopsies, indication for biopsy and CXCL10-triggered biopsies within the first year post-transplant
Time frame: First year post-transplant
Safety assessed by biopsy-related complications within the first year post-transplant
Time frame: First year post-transplant
Safety assessed by immunosuppression-related complications as infections and cancer within the first year post-transplant
Time frame: First year post-transplant
Graft and its cause
Time frame: yearly up to 10 years
Death and its cause
Time frame: yearly up to 10 years
Allograft function measured by creatinine and eGFR
Time frame: yearly up to 10 years
Proteinuria
Time frame: yearly up to 10 years
Biopsy-proven rejection
Time frame: yearly up to 10 years
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 11 Aug 2022.
- Derived from this study: PubMed 37228005Hirt-Minkowski P, Handschin J, Stampf S, Hopfer H, Menter T, Senn L, Honger G, Wehmeier C, Amico P, Steiger J, Koller M, Dickenmann M, Schaub S. Randomized Trial to Assess the Clinical Utility of Renal Allograft Monitoring by Urine CXCL10 Chemokine. J Am Soc Nephrol. 2023 Aug 1;34(8):1456-1469. doi: 10.1681/ASN.0000000000000160. Epub 2023 May 25.
- Individual participant dataSharing planned: Undecided
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(TNX-1500) in Kidney Transplant Recipients
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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
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Not yet recruitingObservational study
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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.
Stefan Schaub, MD, MSc principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rejection treatment according to clinical standard-of-care in people with Renal Transplant Rejection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 3 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 11 Aug 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 Switzerland. 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?
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?
Graft loss not due to death of the patient (time frame: First year post-transplant). 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 NCT03140514, which also lists 1 linked publication.
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 11 Aug 2022.