Protection From Acute Kidney Injury (AKI) With Basis Treatment

  • STATUS
    Recruiting
  • End date
    Dec 12, 2024
  • participants needed
    238
  • sponsor
    Mayo Clinic
Updated on 12 June 2021
renal injury

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 and Pterostilbene) in preventing acute kidney injury (AKI) in patients undergoing complex aortic aneurysm repair and open aortic arch reconstruction.

Details
Condition Acute renal failure, AKI, acute kidney injury
Treatment Placebo, Nicotinamide Riboside + Pterostilbene
Clinical Study IdentifierNCT04342975
SponsorMayo Clinic
Last Modified on12 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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