Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06538961 · ClinicalTrials.gov registry record
Immune Registry for BK in Kidney Transplant Recipients
A clinical trial of Kidney Transplant; Complications and BK Virus Infection, sponsored by Virginia Commonwealth University.
- Recruiting
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT06538961: Recruiting study of Kidney Transplant; Complications and BK Virus Infection, sponsored by Virginia Commonwealth University.
NCT06538961 is a study of Kidney Transplant; Complications and BK Virus Infection that is actively recruiting participants, run by Virginia Commonwealth University. The registered enrollment target is 60 participants, below the 119-participant average among 19 other Kidney Transplant; Complications trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06538961, a study of Kidney Transplant; Complications and BK Virus Infection, is actively recruiting participants, sponsored by Virginia Commonwealth University.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients. BK nephropathy can affect 8-15% of patients after KT causing acute kidney injury, increased risk of rejection and fibrosis leading to additional hospital stays, increasing overall health care cost burden, and in some cases graft loss. The exact pathogenesis and treatment options for BK nephropathy are not clearly understood. It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipient's latent infection. Irrespective of etiology, the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection.
Primary Outcome
Assessing the effect of kidney transplant induction and maintenance triple immunosuppression on humoral and cellular responses against BK virus compared at pre- and post-KT through clinical chart review, abnormal value or result from a clinical or laboratory evaluation, by assessing humoral and cellular responses against BK virus through BK specific T cell response, immunoglobulin G targeting BK levels, urine gene expression test to detect for BK virus and rejection.
Conditions Studied
Interventions
- OTHER Blood samples: Main Study group
- OTHER Data Collection
- OTHER Urine Sample- Main Study group
- OTHER Urine sample- Sub-study group
- OTHER Blood sample: Sub-study group
Study Locations (1)
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-05-29 |
| Est. Completion | 2026-05 |
What NCT06538961 shows while recruiting
NCT06538961 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 119-participant average among 19 other Kidney Transplant; Complications trials with a reported enrollment target (50% lower).
The record links to 2 conditions, with Kidney Transplant; Complications appearing as the primary indexed condition, and to 5 interventions - of which Blood samples: Main Study group is the first listed.
NCT06538961 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT06538961 about?
NCT06538961 is a clinical study titled "Immune Registry for BK in Kidney Transplant Recipients". Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infe...
What is the current status of trial NCT06538961?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2024-05-29. Estimated completion is 2026-05.
What conditions does trial NCT06538961 study?
This clinical trial studies the following conditions: Kidney Transplant; Complications, BK Virus Infection.
What interventions are being tested in trial NCT06538961?
The interventions under investigation include: Blood samples: Main Study group (OTHER), Data Collection (OTHER), Urine Sample- Main Study group (OTHER), Urine sample- Sub-study group (OTHER), Blood sample: Sub-study group (OTHER).
Who is sponsoring clinical trial NCT06538961?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06538961 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Transplant; Complications
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06538961's enrollment target sits among peer trials
60 13th of 19 higher than 5 of 19 other Kidney Transplant; Complications trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Transplant; Complications trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Feasibility Study for the Comprehensive Overweight/Obesity Management Pre-Kidney Transplant (COMPKT) Program
RECRUITING · NA
-
The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study
RECRUITING · Phase 2
-
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
RECRUITING · Phase 3
-
Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients
RECRUITING · Phase 4
-
Dietary Intervention to Improve Kidney Transplant Outcomes
RECRUITING · NA
-
Double Voiding and Post-transplant UTI
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI