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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342975
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : February 11, 2022
Sponsor:
Collaborator:
Elysium Health
Information provided by (Responsible Party):
Bernardo C. Mendes, 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.

Condition or disease Intervention/treatment Phase
AKI Drug: Nicotinamide Riboside + Pterostilbene Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
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
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
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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 4 capsules of Basis™ (each capsule 125 mg of NR and 25 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

Placebo Comparator: Placebo
Correspondent placebo, a capsule not containing the active component.
Drug: Placebo
The correspondent placebo will be administered in a regimen of 4 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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. Myocardial infarction [ Time Frame: 6 months ]
    The secondary endpoint will be change in the incidence of myocardial infarction

  2. Bowel ischemia [ Time Frame: 6 months ]
    The secondary endpoint will be change in the incidence of bowel ischemia

  3. Spinal cord injury [ Time Frame: 6 months ]
    The secondary endpoint will be change in the incidence of spinal cord injury

  4. 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)

  5. 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

  6. Quinolinate and Tryptophan [ Time Frame: 6 months ]
    Quinolinate and Tryptophan levels in urine



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342975


Contacts
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Contact: Karina S Kanamori Mendes, MD 507-266-2173 mendes.karina@mayo.edu
Contact: Jainnee Sacksith 507-538-5679 rstendovascularresearch@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karina S Kanamori Mendes, MD         
Sponsors and Collaborators
Mayo Clinic
Elysium Health
Investigators
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Principal Investigator: Bernardo Mendes, MD Mayo Clinic
Additional Information:
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Responsible Party: Bernardo C. Mendes, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04342975    
Other Study ID Numbers: 18-000162
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bernardo C. Mendes, Mayo Clinic:
AKI
open vascular surgery
endovascular surgery
aortic arch reconstruction
Acute Kidney Injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents