Kidney Transplantation Clinical Trial
Official title:
Phase II, Open-label, Randomized, Multiple Ascending Dose Confirmation of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation (BASTION)
This is a Phase II, multicenter, open-label, randomized, standard of care (SOC) controlled, multiple ascending dose study to assess the safety and tolerability of IV Brincidofovir (BCV) in subjects with BKV infection after kidney transplantation. The study will be conducted at multiple study sites in several countries including Australia and Japan. Subjects who meet eligibility criteria will be enrolled in the study and will be randomized and assigned to BCV or SOC (defined as use of the same immunosuppressant administered during prescreening) before receipt of the first dose of study drug in both the Dose Escalation Phase and the Expansion Phase.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | February 16, 2025 |
Est. primary completion date | December 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Male or female, at least 18 years of age at the time of signing the informed consent at screening. - Kidney transplant recipient. "BK viral load increase and = 3.6 log IU/mL" at 2 weeks post immunosuppression reduction or "BK viral load does not decrease by = 0.3 log IU/mL" at 4 weeks post immunosuppression reduction during prescreening. (Note: Immunosuppressant reduction needs to be continued during the screening period). - eGFR = 30 mL/min. - Subjects under immunosuppression with tacrolimus, MMF/Myfortic, and/or corticosteroid. Exclusion Criteria: - Subjects who weigh = 120 kg. - National Institutes of Health/NCI CTCAE Grade 2 or higher diarrhea (ie, increase of = 4 stools per day over usual pretransplant stool output) within 7 days before Day 1. - Poor clinical prognosis, including active malignancy or use of vasopressors other than low dose (eg, = 5 µg/kg/min) dopamine for renal perfusion within 7 days before Day 1. - Use of renal replacement therapy within 7 days before Day 1. - History of intolerance to cidofovir or related compounds (ie, other nucleotide derivatives [adefovir or tenofovir]) |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | |
Australia | Austin Health | Melbourne | |
Australia | The Royal Melbourne Hospital | Melbourne | |
Japan | Tokyo Medical University Hachioji Medical Center | Hachioji | |
Japan | Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital | Nagoya | |
Japan | Osaka General Medical Center | Osaka | |
Japan | Osaka Metropolitan University Hospital | Osaka | |
Japan | Hokkaido University Hospital | Sapporo | |
Japan | Sapporo City General Hospital | Sapporo | |
Japan | Jichi Medical University Hospital | Shimotsuke | |
Japan | Tokyo Women's Medical University Hospital | Shinjuku-ku | |
Japan | Osaka University Hospital | Suita | |
Japan | Fujita Health University Hospital | Toyoake | |
Japan | Yokohama City University Medical Center | Yokohama |
Lead Sponsor | Collaborator |
---|---|
SymBio Pharmaceuticals |
Australia, Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment-emergent adverse events (TEAEs) | Incidence of TEAEs of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 severity and serious adverse events
Incidence of treatment-related TEAEs Incidence of adverse events (AEs) requiring permanent discontinuation of BCV Absolute and changes over time in safety laboratory parameters (ie, hematology, blood chemistry, and urinalysis) |
from the time of administration of the first dose of study drug through the follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period)) | |
Primary | Antiviral Effects | Change from baseline in BK viral load in plasma measured through follow-up for each subject. Change from baseline in BK viral load in urine measured through follow-up for each subject. Peak BK viral load in plasma from Week 2 Day 1 through follow-up for each subject. Time-averaged area under the viremia-time curve for BK viral load in plasma from baseline through follow-up for each subject. | From baseline to follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period)) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04910867 -
APOL1 Genetic Testing Program for Living Donors
|
N/A | |
Completed |
NCT02723591 -
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
|
Phase 4 | |
Completed |
NCT05945511 -
Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
|
||
Completed |
NCT02234349 -
Bile Acids and Incretins in Pancreas Kidney Transplant Patients
|
N/A | |
Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 | |
Recruiting |
NCT05917795 -
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
|
N/A | |
Not yet recruiting |
NCT05934383 -
Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
|
N/A | |
Withdrawn |
NCT04936971 -
Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response
|
Phase 4 | |
Not yet recruiting |
NCT04540640 -
Oxygenated Machine Preservation in Kidney Transplantation
|
N/A | |
Not yet recruiting |
NCT03090828 -
Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease
|
N/A | |
Recruiting |
NCT02908139 -
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients
|
N/A | |
Terminated |
NCT02417870 -
Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT02560558 -
Bela 8 Week Dosing
|
Phase 4 | |
Recruiting |
NCT02154815 -
Pre-emptive Kidney Transplantation Quality of Life
|
N/A | |
Completed |
NCT02235571 -
iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
|
N/A | |
Enrolling by invitation |
NCT01905514 -
ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients
|
N/A | |
Completed |
NCT02147210 -
Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1
|
N/A | |
Recruiting |
NCT01699360 -
The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients
|
Phase 4 | |
Terminated |
NCT01436305 -
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
|
Phase 2 | |
Completed |
NCT01672957 -
ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil)
|
N/A |