NCT_ID: NCT05836636
Clinical Trial Link
Brief Summaries
| Sequence: | 30856282 |
| Description | Kidney transplant recipients (KTRs) suffer from immunosuppression-related adverse events (iRAEs), such as infections and malignancy from chronic immunosuppression exposure but are also at risk of graft loss from rejection with under-immunosuppression. Biomarkers that predict both iRAEs and rejection and allow individualisation of immunosuppression exposure are lacking. While plasma viral DNA levels of Torque Teno Virus (TTV), a widely prevalent, non-pathogenic virus, have been shown to predict both iRAE and rejection in incident KTRs within 1 year after transplant, its role for prevalent KTRs on stable immunosuppression is unclear. The investigators hypothesise that plasma TTV levels can predict iRAEs and rejection in KTRs on stable immunosuppression and propose a pilot study to pursue three specific aims: (1) To determine the TTV levels and its relationship with clinical factors affecting the 'net state of immunosuppression' in prevalent KTRs. (2) To analyse the prognostic value of TTV levels for iRAEs and rejection in prevalent KTRs. (3) To compare the prognostic performance of TTV levels to commonly available biomarkers and composite prognostic scores. The investigators seek pursue these aims by performing a single-centre, prospective, observational cohort study of 172 KTRs on stable immunosuppression for more than 3 months. TTV levels will be measured, using the TTV R-GENE® kit, upon recruitment and when kidney allograft biopsies are performed. Subjects will be monitored for iRAEs and rejection for at least 12 months. The study will provide data on the distribution of TTV levels in a prevalent cohort of KTRs and analyse its relationship with clinical factors and important clinical outcomes. If the study indicates that TTV may be predictive of iRAEs and rejection, the investigators aim to conduct further studies including interventional studies using TTV levels to guide immunosuppression. Ultimately, the investigators aim to use TTV as a biomarker to optimise long-term immunosuppression exposure, reduce the risk of iRAEs without increase in rejection, and improve long-term outcomes for KTRs. |
Studies
| Study First Submitted Date | 2023-04-19 |
| Study First Posted Date | 2023-05-01 |
| Last Update Posted Date | 2023-07-07 |
| Start Month Year | June 27, 2023 |
| Primary Completion Month Year | March 31, 2025 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-07-07 |
Facilities
| Sequence: | 200605351 |
| Status | Recruiting |
| Name | Singapore General Hospital |
| City | Singapore |
| Zip | 767972 |
| Country | Singapore |
Facility Contacts
| Sequence: | 28184902 |
| Facility Id | 200605351 |
| Contact Type | primary |
| Name | Quan Yao Ho, MBBS, MRCP, MMed, FAMS |
| ho.quan.yao@singhealth.com.sg | |
| Phone | 62223322 |
Conditions
| Sequence: | 52325973 | Sequence: | 52325974 | Sequence: | 52325975 |
| Name | Kidney Transplant Infection | Name | Kidney Transplant Rejection | Name | Kidney Transplant; Complications |
| Downcase Name | kidney transplant infection | Downcase Name | kidney transplant rejection | Downcase Name | kidney transplant; complications |
Id Information
| Sequence: | 40269332 |
| Id Source | org_study_id |
| Id Value | 2023/2170 |
Countries
| Sequence: | 42688723 |
| Name | Singapore |
| Removed | False |
Interventions
| Sequence: | 52636945 |
| Intervention Type | Other |
| Name | Torque teno virus DNA measurement |
| Description | Torque teno virus DNA level will be obtained from all study subjects upon recruitment, when subjects are admitted and when subjects undergo kidney allograft biopsies. |
Design Outcomes
| Sequence: | 177950735 | Sequence: | 177950736 | Sequence: | 177950737 | Sequence: | 177950738 | Sequence: | 177950739 | Sequence: | 177950740 | Sequence: | 177950741 | Sequence: | 177950742 | Sequence: | 177950743 | Sequence: | 177950744 | Sequence: | 177950745 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Severe infections defined as any infection requiring hospitalization | Measure | Opportunistic infections | Measure | De novo malignancy | Measure | Calcineurin inhibitor nephrotoxicity (biopsy-proven) | Measure | Rejection (biopsy-proven) | Measure | Glomerulonephritis – de novo or recurrent (biopsy-proven) | Measure | Graft function | Measure | Graft loss | Measure | Mortality | Measure | Immunosuppression-related adverse event | Measure | Immune-mediated adverse event |
| Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year | Time Frame | 1 year |
| Description | Any infection requiring hospitalization | Description | intracellular bacteria, mycobacteria, Listeria monocytogenes, and Nocardia spp., herpesviruses (CMV, HSV, and VZV), polyomaviruses, yeasts (Candida and Cryptococcus), molds (invasive aspergillosis and mucormycosis), and parasites (Toxoplasma gondii, PJP, and Leishmania) | Description | De novo malignancy | Description | Calcineurin inhibitor nephrotoxicity (biopsy-proven) | Description | With and without borderline T cell-mediated rejection | Description | serum creatinine, estimated glomerular filtration rate by the CKD-EPI equation and urine protein-to-creatinine ratio | Description | Censored and non-censored for death | Description | All-cause and cause-specific – i.e., infection, malignancy, cardiovascular, others | Description | Composite outcome of severe infections defined as any infection requiring hospitalization, opportunistic infections, de novo malignancy and calcineurin inhibitor nephrotoxicity | Description | Composite outcome of rejection (biopsy-proven) and glomerulonephritis (biopsy-proven) |
Sponsors
| Sequence: | 48464307 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Singapore General Hospital |
Central Contacts
| Sequence: | 12047433 |
| Contact Type | primary |
| Name | Quan Yao Ho, MBBS, MRCP, MMed, FAMS |
| Phone | 6563214436 |
| ho.quan.yao@singhealth.com.sg | |
| Role | Contact |
Eligibilities
| Sequence: | 30855063 |
| Sampling Method | Probability Sample |
| Gender | All |
| Minimum Age | 21 Years |
| Maximum Age | 99 Years |
| Healthy Volunteers | No |
| Population | Kidney transplant recipients (KTRs) on stable doses of immunosuppression for more than 3 months |
| Criteria | Inclusion Criteria: Kidney transplant recipients on follow up at Singapore General Hospital (SGH) More than 21 years old On stable doses of immunosuppression for more than 3 months Exclusion Criteria: Titration of immunosuppression (e.g. for rejection or infection) less than 3 months ago Active infection requiring treatment Less than 21 years old Unable to provide informed consent |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254311568 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2023 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 21 |
| Maximum Age Num | 99 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 10 |
Designs
| Sequence: | 30600905 |
| Observational Model | Cohort |
| Time Perspective | Prospective |
Responsible Parties
| Sequence: | 28967414 |
| Responsible Party Type | Sponsor |
Ipd Information Types
| Sequence: | 3346410 | Sequence: | 3346411 | Sequence: | 3346412 |
| Name | Study Protocol | Name | Statistical Analysis Plan (SAP) | Name | Clinical Study Report (CSR) |