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

AKI Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342975
• Other study ID #: 18-000162
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: March 14, 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• AKI

Intervention

Drug:
• Nicotinamide Riboside + Pterostilbene
It will be administered a total of 1000 mg/day of NR and 200 mg/day of Ptero in a regimen of 2 capsules of Basis™ (each capsule 250 mg of NR and 50 mg of Ptero) 2 times a day by mouth for 2 weeks before surgery and 6 weeks after surgery. Each intake has to be apart from each other by, at least, 6 hours of interval.
• Placebo
The correspondent placebo will be administered in a regimen of 2 capsules 2 times a day by mouth for 2 weeks before surgery and 6 weeks after surgery. Each intake has to be apart from each other by, at least, 6 hours of interval.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Elysium Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AKI	The primary endpoint will be change in incidence of AKI measured by estimated glomerular filtration rate (eGFR) using the RIFLE criteria.	6 months
Secondary	Myocardial infarction	The secondary endpoint will be change in the incidence of myocardial infarction	6 months
Secondary	Bowel ischemia	The secondary endpoint will be change in the incidence of bowel ischemia	6 months
Secondary	Spinal cord injury	The secondary endpoint will be change in the incidence of spinal cord injury	6 months
Secondary	Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR)	NAD, NMN, NR levels in peripheral blood mononuclear cells (PBMCs)	6 months
Secondary	Tissue Inhibitor of Metalloproteinases 2 (TIMP2), Kidney Injury Molecule 1 (KIM-1), Insulin-like Growth Factor-binding Protein 7 (IGFBP7)	TIMP2, KIM-1, IGFBP7 levels in urine	6 months
Secondary	Quinolinate and Tryptophan	Quinolinate and Tryptophan levels in urine	6 months