Status:
COMPLETED
Protection From Acute Kidney Injury (AKI) With Basis™ Treatment
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Elysium Health
Conditions:
AKI
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a single-center, prospective, randomized, double-blinded, placebo-controlled phase II clinical trial to evaluate the efficacy of "NAD+ supplementation" with Basis™ (Nicotinamide Riboside...
Eligibility Criteria
Inclusion
- A patient may be included in the study if the following conditions are present:
- Male or female;
- Age \> 18 years old;
- Patients who match the criteria for indication of elective open aortic arch replacement or repair:
- Total arch;
- Non-total arch;
- Patients who match the criteria for indication of elective complex aortic aneurysm repair has to respect the following conditions:
- a. Patients undergoing complex aortic aneurysm open reconstruction with a suprarenal clamp; i. thoracoabdominal aortic aneurysms Crawford extent I to IV ; ii. abdominal aortic aneurysms of juxtarenal, pararenal, or paravisceral type; b. For endovascular approach: i. patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and known stage III or IV of chronic kidney disease (CKD); ii. patients with pararenal or thoracoabdominal aortic aneurysms Crawford extent I to IV and solitary or single functioning kidney and known stage III or IV CKD;
- Patients will be allowed to participate in concomitant endovascular aortic stent-graft trials and prospective cohort studies as long as these do not involve another investigational study drug.
Exclusion
- Patients must be excluded from the study if any of the following conditions are true:
- 2.1 General Exclusion Criteria
- Unwilling to comply with the follow-up schedule;
- Inability or refusal to give informed consent by the patient or a legally authorized representative;
- Pregnant or breastfeeding;
- Subject who takes multivitamins containing vitamin B3 derivatives in a dose \> 200 mg/day; 5.2.2 Clinical / Laboratory Exclusion Criteria
- Renal failure defined as eGFR\< 15 mL/min/1.73m2
- Patients in permanent Renal Replacement Therapy;
- Patients with chronic liver disease: Child-Pugh score class B and C; 5.2.3 Medication Exclusion Criteria
- Patients in chemotherapy scheme;
- Patients taking any immunosuppressant, except for corticosteroids;
- Patients taking any of these well-known P-glycoprotein substrates: digoxin, fexofenadine, indinavir, sirolimus.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04342975
Start Date
December 1 2020
End Date
March 14 2024
Last Update
April 23 2024
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905