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

Primary Purpose

AKI

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nicotinamide Riboside + Pterostilbene

Placebo

About this trial

This is an interventional prevention trial for AKI focused on measuring AKI, open vascular surgery, endovascular surgery, aortic arch reconstruction, Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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;
Subject who takes multivitamins containing vitamin B3 derivatives in a dose > 200 mg/day; 5.2.2 Clinical / Laboratory Exclusion Criteria
Renal failure defined as eGFR< 15 mL/min/1.73m2
Patients in permanent Renal Replacement Therapy;
Patients with chronic liver disease: Child-Pugh score class B and C; 5.2.3 Medication Exclusion Criteria
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.

Sites / Locations

Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Basis

Placebo

Arm Description

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.

Correspondent placebo, a capsule not containing the active component.

Outcomes

Primary Outcome Measures

AKI

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

Secondary Outcome Measures

Myocardial infarction

The secondary endpoint will be change in the incidence of myocardial infarction

Bowel ischemia

The secondary endpoint will be change in the incidence of bowel ischemia

Spinal cord injury

The secondary endpoint will be change in the incidence of spinal cord injury

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

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)

TIMP2, KIM-1, IGFBP7 levels in urine

Quinolinate and Tryptophan

Quinolinate and Tryptophan levels in urine

Full Information

NCT ID

NCT04342975

First Posted

August 13, 2019

Last Updated

February 21, 2023

Sponsor

Mayo Clinic

Collaborators

Elysium Health

1. Study Identification

Unique Protocol Identification Number

NCT04342975

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

Elysium Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

AKI

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

238 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Basis

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Correspondent placebo, a capsule not containing the active component.

Intervention Type

Drug

Intervention Name(s)

Nicotinamide Riboside + Pterostilbene

Other Intervention Name(s)

Basis

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

AKI

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Myocardial infarction

Description

The secondary endpoint will be change in the incidence of myocardial infarction

Time Frame

6 months

Title

Bowel ischemia

Description

The secondary endpoint will be change in the incidence of bowel ischemia

Time Frame

6 months

Title

Spinal cord injury

Description

The secondary endpoint will be change in the incidence of spinal cord injury

Time Frame

6 months

Title

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

Description

NAD, NMN, NR levels in peripheral blood mononuclear cells (PBMCs)

Time Frame

6 months

Title

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

Description

TIMP2, KIM-1, IGFBP7 levels in urine

Time Frame

6 months

Title

Quinolinate and Tryptophan

Description

Quinolinate and Tryptophan levels in urine

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Patients must be excluded from the study if any of the following conditions are true: 5.2.1 General Exclusion Criteria 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; Subject who takes multivitamins containing vitamin B3 derivatives in a dose > 200 mg/day; 5.2.2 Clinical / Laboratory Exclusion Criteria Renal failure defined as eGFR< 15 mL/min/1.73m2 Patients in permanent Renal Replacement Therapy; Patients with chronic liver disease: Child-Pugh score class B and C; 5.2.3 Medication Exclusion Criteria 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karina S Kanamori Mendes, MD

Phone

507-266-2173

mendes.karina@mayo.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Haen

Phone

507-538-7403

rstendovascularresearch@mayo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernardo Mendes, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karina S Kanamori Mendes, MD

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

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

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