Protection From Acute Kidney Injury (AKI) With Basis™ Treatment

Phase 2

Completed

• Conditions: AKI
• Interventions: Drug: Placebo; Drug: Nicotinamide Riboside + Pterostilbene

• Registration Number: NCT04342975
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Study Start: 2020-12-01
• Primary Completion: 2024-03-14
• Study Completion: 2024-03-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Correspondent placebo, a capsule not containing the active component.
Basis	Nicotinamide Riboside + Pterostilbene	The investigational product, Basis™, contains a synthetic NR that is nature-identical to naturally-occurring NR, does not induce flushing or pruritus and has no effect on lipid levels. Also contains Pterostilbene (Ptero) that is a stilbenoid compound, characterized by two aromatic rings connected by a methylene bridge backbone, and it has two methoxy groups and one hydroxyl group extending from the aromatic rings.

Primary Outcome Measures

Name	Time	Method
AKI	6 months	The primary endpoint will be change in incidence of AKI measured by estimated glomerular filtration rate (eGFR) using the RIFLE criteria.

Secondary Outcome Measures

Name	Time	Method
Quinolinate and Tryptophan	6 months	Quinolinate and Tryptophan levels in urine
Bowel ischemia	6 months	The secondary endpoint will be change in the incidence of bowel ischemia
Spinal cord injury	6 months	The secondary endpoint will be change in the incidence of spinal cord injury
Myocardial infarction	6 months	The secondary endpoint will be change in the incidence of myocardial infarction
Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR)	6 months	NAD, NMN, NR levels in peripheral blood mononuclear cells (PBMCs)
Tissue Inhibitor of Metalloproteinases 2 (TIMP2), Kidney Injury Molecule 1 (KIM-1), Insulin-like Growth Factor-binding Protein 7 (IGFBP7)	6 months	TIMP2, KIM-1, IGFBP7 levels in urine

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States