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

NCT04342975 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 18-000162
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

AKI

Keywords

AKI; open vascular surgery; endovascular surgery; aortic arch reconstruction; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Myocardial infarction

  6 months

• Bowel ischemia

  6 months

• Spinal cord injury

  6 months

• Nicotinamide Adenine Dinucleotide (NAD), Nicotinamide Mononucleotide (NMN), and Nicotinamide Riboside (NR)

  6 months

• Tissue Inhibitor of Metalloproteinases 2 (TIMP2), Kidney Injury Molecule 1 (KIM-1), Insulin-like Growth Factor-binding Protein 7 (IGFBP7)

  6 months

Study Arms (2)

Basis

ACTIVE COMPARATOR

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.

Drug: Nicotinamide Riboside + Pterostilbene

Placebo

PLACEBO COMPARATOR

Correspondent placebo, a capsule not containing the active component.

Drug: Placebo

Interventions

Nicotinamide Riboside + Pterostilbene DRUG

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.

Also known as: Basis

Basis

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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;
• 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.

You may not qualify if:

• Patients must be excluded from the study if any of the following conditions are true:
• 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;
• Renal failure defined as eGFR\< 15 mL/min/1.73m2
• Patients in permanent Renal Replacement Therapy;
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Elysium Health: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

nicotinamide-beta-riboside; Pterocarpus marsupium; Radial Basis Function Networks

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Neural Networks, Computer; Mathematical Concepts

Study Officials

• Bernardo Mendes, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: April 13, 2020
• Study Start: December 1, 2020
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)