Last reviewed · How we verify
NCT05026021: BK-VIR
Prediction of BKvirus Nephropathy Risk by the NEPHROVIR Method in Kidney Transplant Patients With BKvirus Viremia
trial testing Blood sample in BK Virus Infection in 41 participants. Status unknown.
2 September 2023
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 41 |
| Start date | 2 September 2021 |
| Primary completion | 2 September 2023 |
| Estimated completion | 2 September 2025 |
| Sites | 5 locations across France |
Drugs / interventions tested
- Blood sample — full drug profile →
Conditions studied
- BK Virus Infection — all drugs for BK Virus Infection →
- Nephropathy — all drugs for Nephropathy →
- Kidney Transplantation — all drugs for Kidney Transplantation →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
18 and older, any sex, with BK Virus Infection or Nephropathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
BKvirus associated nephropathy (BKvAN) is a major complication in kidney transplantation. Due to BKvirus (BKv) intra-graft replication, BKvAN affects nearly 10% of patients and causes graft loss in more than 50% of cases. Without current antiviral therapy, the treatment consists of minimizing immunosuppression, secondarily exposing the patient to a graft rejection risk. Impaired BKv specific T cell response plays a crucial role in the BKvAN pathophysiology. Several teams, including ours, have demonstrated a profound impairment of BKv specific T cell response during BKvAN. Immunovirological monitoring allows an individual assessment of viral reactivation risk based on the anti-viral immune response. Our group has developed the NEPHROVIR method. This non-invasive biological method allows the identification of BKvAN risk level. The aim of this work is to evaluate, by the NEPHROVIR method, the risk to develop a BKvAN with renal impairment in kidney transplant recipients with sustained BKv viremia. The investigators propose the BK-VIR study. This is a prospective multicentric study involving 100 kidney transplant recipients with sustained BKv viremia. The aim of this work is to evaluate the NEPHROVIR method as an innovative immunovirological surveillance method for predicting the risk of BKvAN occurrence. The characterization of individual BKvAN risk level could help in the individualized follow-up and management of immunosuppression in patients. The long-term objective would be to diagnose very early, or even anticipate, the occurrence of BKvAN and to allow early readjustment of the immunosuppressive treatment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05026021
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Blood sample
Trials testing the same drug.
- NCT07226466 — Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer · not yet recruiting
- NCT07313878 — Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Micros · NA · recruiting
- NCT06273800 — Chemosensitivity During Phases of the Menstrual Cycle in Breast Cancer Patients · NA · recruiting
- NCT07030205 — Resting-state Imaging and OSteoporosiS · NA · recruiting
- NCT07295808 — Identification and Characterisation of IgA With Nephritogenic Potential in IgA Deposition Nephropathies (Rep-IgAN) · NA · recruiting
Other recruiting trials for BK Virus Infection
Currently open trials in the same condition.
- NCT05101213 — Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus S · Phase 1 · recruiting
- NCT05264259 — New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies · recruiting
- NCT02479698 — Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus · Phase 2 · recruiting
Other Assistance Publique - Hôpitaux de Paris trials
Trials by the same sponsor.
- NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
- NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
- NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
- NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
- NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05026021 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 3 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05026021.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing