Clinical trial NCT04342975: Protection From Acute Kidney Injury (AKI) With Basis™ Treatment
Official title: A Phase II, Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy of BASIS™ (Nicotinamide Riboside and Pterostilbene) Treatment for Kidney Protection in Patients Treated by Complex Aortic Aneurysm Repair and Aortic Arch Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: AKI
Keywords: AKI
open vascular surgery
endovascular surgery
aortic arch reconstruction
Acute Kidney Injury
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Elysium Health
First posted: 2020-04-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion Criteria:

* A patient may be included in the study if the following conditions are present:

  1. Male or female;
  2. Age \> 18 years old;
  3. Patients who match the criteria for indication of elective open aortic arch replacement or repair:

     1. Total arch;
     2. Non-total arch;
  4. 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;
  5. 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:

5.2.1 General Exclusion Criteria

1. Unwilling to comply with the follow-up schedule;
2. Inability or refusal to give informed consent by the patient or a legally authorized representative;
3. Pregnant or breastfeeding;
4. Subject who takes multivitamins containing vitamin B3 derivatives in a dose \> 200 mg/day; 5.2.2 Clinical / Laboratory Exclusion Criteria
5. Renal failure defined as eGFR\< 15 mL/min/1.73m2
6. Patients in permanent Renal Replacement Therapy;
7. Patients with chronic liver disease: Child-Pugh score class B and C; 5.2.3 Medication Exclusion Criteria
8. Patients in chemotherapy scheme;
9. Patients taking any immunosuppressant, except for corticosteroids;
10. Patients taking any of these well-known P-glycoprotein substrates: digoxin, fexofenadine, indinavir, sirolimus.

Primary outcomes:
measure: AKI
timeFrame: 6 months
Secondary outcomes:
measure: Myocardial infarction
timeFrame: 6 months
measure: Bowel ischemia
timeFrame: 6 months
measure: Spinal cord injury
timeFrame: 6 months
measure: Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR)
timeFrame: 6 months
measure: Tissue Inhibitor of Metalloproteinases 2 (TIMP2), Kidney Injury Molecule 1 (KIM-1), Insulin-like Growth Factor-binding Protein 7 (IGFBP7)
timeFrame: 6 months
measure: Quinolinate and Tryptophan
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bernardo Mendes, MD
role: PRINCIPAL_INVESTIGATOR
References: