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

• ClinicalTrials.gov Identifier: NCT04342975
• Recruitment Status: Completed
• First Posted: April 13, 2020
• Last Update Posted: April 23, 2024
• Sponsor: Mayo Clinic
• Collaborator: Elysium Health
• Information provided by (Responsible Party): Bernardo C. Mendes, Mayo Clinic

Tracking Information

• First Submitted Date: August 13, 2019
• First Posted Date: April 13, 2020
• Last Update Posted Date: April 23, 2024
• Actual Study Start Date: December 1, 2020
• Actual Primary Completion Date: March 14, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 8, 2020)

AKI [ Time Frame: 6 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 8, 2020)

• Myocardial infarction [ Time Frame: 6 months ]
  The secondary endpoint will be change in the incidence of myocardial infarction
• Bowel ischemia [ Time Frame: 6 months ]
  The secondary endpoint will be change in the incidence of bowel ischemia
• Spinal cord injury [ Time Frame: 6 months ]
  The secondary endpoint will be change in the incidence of spinal cord injury
• Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR) [ Time Frame: 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) [ Time Frame: 6 months ]
  TIMP2, KIM-1, IGFBP7 levels in urine
• Quinolinate and Tryptophan [ Time Frame: 6 months ]
  Quinolinate and Tryptophan levels in urine

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

• Condition: 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.
  Other Name: Basis
• Drug: 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.

Study Arms

• Active Comparator: Basis
  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.
  Intervention: Drug: Nicotinamide Riboside + Pterostilbene
• Placebo Comparator: Placebo
  Correspondent placebo, a capsule not containing the active component.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 22, 2024): 54
• Original Estimated Enrollment (submitted: April 8, 2020): 238
• Actual Study Completion Date: March 14, 2024
• Actual Primary Completion Date: March 14, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04342975
• Other Study ID Numbers: 18-000162
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Bernardo C. Mendes, Mayo Clinic
• Original Responsible Party: Eduardo N. Chini, Mayo Clinic, Principal Investigator
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current
• Collaborators: Elysium Health

Investigators

• Principal Investigator: Bernardo Mendes, MD; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: April 2024