Acute Kidney InjuryBAKISNCT03176628
Pharmacokinetics, Pharmacodynamics and Safety of Basis in Acute Kidney Injury Study
A study testing Basis in people with Acute Kidney Injury, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will determine the pharmacokinetics, pharmacodynamics and safety of escalating doses of Basis following twice daily oral administration in patients with acute kidney injury (AKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Basis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 11 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female hospitalized patients, age ≥ 18 years.
- Patients who have developed AKI (defined by an increase in serum creatinine by ≥0.3 mg/dL within 48 hours; or an increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days).
- Adequate hematological and liver function, as assessed by the following laboratory requirements:
- Hemoglobin ≥10.0 g/dL
- Absolute neutrophil count (ANC) ≥1,500/mm3
- Platelet count 100,000/mm3
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- Total bilirubin ≤1.5 x upper limit of normal (ULN).
- ALT and AST ≤2.5 x ULN.
- Able to provide written informed consent in compliance with the Human Investigation Review Committee (IRB).
Who cannot join
- Exposure to any investigational agent within 30 days prior to enrollment.
- Known allergy to any of the study drugs or their excipients.
- Currently pregnant (confirmed with a positive serum pregnancy test) or nursing.
- Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol.
- Baseline CKD stage 4-5 (eGFR<30 mL/minute/1.73 m2 as determined using the Modification of Diet in Renal Disease (MDRD) equation; in cases where the MDRD equation may not be suitable, a 24 hour urine creatinine clearance test may be substituted), prior to current hospitalization
- Any malignancy with the exception of cervical carcinoma in situ,nonmelanoma skin cancer, or superficial bladder tumors that have been successfully and curatively treated with no evidence of recurrent or residual disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02118
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Stepwise Study of the Pharmacokinetics, Pharmacodynamics & Safety of Escalating Doses of Basis (Nicotinamide Riboside and Pterostilbene) in Patients With Acute Kidney Injury (AKI)
This study will determine the pharmacokinetics, pharmacodynamics and safety of escalating doses of Basis following twice daily oral administration in patients with acute kidney injury (AKI). Basis is a commercially available nutritional supplement consisting of nicotinamide riboside (NR) and pterostilbene that acts to increase sirtuin activity.
Read the detailed description
Acute kidney injury (AKI) is common, growing in incidence, and associated with significant morbidity and mortality. Sirtuins are anti-aging enzymes that play a diverse role in cellular energy metabolism and gene regulation. Mice deficient in SIRT1 are more susceptible to developing AKI and sirtuin activation is a potential treatment for AKI.
This is a randomized, double-blind, placebo-controlled, stepwise study of escalating doses of Basis (NR/pterostilbene) in patients with AKI. The study will potentially comprise up to four Steps. The purpose of the stepwise approach is to identify the dose of Basis that achieves at least a 50% and up to 100% increase in white blood cell (WBC) content of nicotinamide adenine dinucleotide (NAD+) without side-effects.
During each Step, Basis (5 patients) or placebo (1 patient) will be given twice a day for 2 days. Patients will have frequent blood sampling performed for a 24 hour period following dosing on Day 1 and then at 48 hr. The measurements in blood will include NR/pterostilbene blood concentrations and NAD+ and NAAD (nicotinic acid adenine dinucleotide) concentrations in WBCs.
- Conditions
- Acute Kidney Injury
- Being tested
- Basis, Placebo
- Keywords
- Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasisDietary supplement
Also called nicotinamide riboside (NR) and pterostilbene
NR is a form of vitamin B3; Pterostilbene is a natural dietary compound and the primary antioxidant component of blueberries
PlaceboDietary supplement
Placebo capsule(s)
| Study group | Role | What they receive |
|---|---|---|
| Basis | Experimental | Nicotinamide riboside (NR) and pterostilbene oral capsules 250mg/50mg (Step 1) twice daily for 2 days. If the study progresses to Steps 2, 3, and 4, then 2x, 3x, and 4x the doses in Step 1 will be administered. Receives: Dietary Supplement: Basis |
| Placebo | Placebo comparator | Capsules identical in appearance and number to the agent used in Steps 1-4. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration [Cmax] of NR
Maximum plasma concentration [Cmax] of NR after oral administration of Basis
Measured: 2 days
Maximum plasma concentration [Cmax] of pterostilbene
Maximum plasma concentration [Cmax] of pterostilbene after oral administration of Basis
Measured: 2 days
Area Under the Curve [AUC] of NR
Area Under the Curve [AUC] of NR after oral administration of Basis
Measured: 2 days
Area Under the Curve [AUC] of pterostilbene
Area Under the Curve [AUC] of pterostilbene after oral administration of Basis
Measured: 2 days
Incidence of Treatment-Emergent Adverse Events (Safety)
Subjects will be interviewed to determine onset of nausea, abdominal pain, vomiting, diarrhea, or rash. Adverse events will be characterized as probably related, probably not related, or unknown
Measured: 2 days
Incidence of Treatment-Emergent Laboratory Abnormalities (Safety)
comprehensive metabolic panel (including liver function tests), complete blood count
Measured: 2 days
Secondary outcomes (3)
NAD+ levels
To determine the increase in NAD+ levels in white blood cells (WBCs) following twice daily Basis administration
Measured: 2 days
Dose finding for 50% increase in NAD+ levels in WBCs
Dose of Basis that leads to 50% increase in NAD+ levels in WBC
Measured: 2 days
Dose finding for 100% increase in NAD+ levels in WBCs
Dose of Basis that leads to 100% increase in NAD+ levels in WBC
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Nov 2017
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 5 subjects in active arm (Basis) : 1 subject in control (placebo)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Elysium Health
- Responsible party
- Principal investigator, Eugene Rhee, Massachusetts General Hospital
- Investigators
- Eugene Rhee, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176628
- Sponsor's protocol ID
- 2017P000908
- Acronym
- BAKIS
- Status last verified
- Jun 2019
- First submitted
- 31 May 2017
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simic P, Vela Parada XF, Parikh SM, Dellinger R, Guarente LP, Rhee EP. Nicotinamide riboside with pterostilbene (NRPT) increases NAD+ in patients with acute kidney injury (AKI): a randomized, double-blind, placebo-controlled, stepwise safety study of escalating doses of NRPT in patients with AKI. BMC Nephrol. 2020 Aug 13;21(1):342. doi: 10.1186/s12882-020-02006-1.
PubMed 32791973
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Stepwise Study of the Pharmacokinetics, Pharmacodynamics & Safety of Escalating Doses of Basis (Nicotinamide Riboside and Pterostilbene) in Patients With Acute Kidney Injury (AKI)
- ClinicalTrials.gov ID
- NCT03176628
- Acronym / sponsor ID
- BAKIS / 2017P000908
- Conditions
- Acute Kidney Injury
- Keywords
- Pharmacokinetics, Pharmacodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Elysium Health
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the pharmacokinetics, pharmacodynamics and safety of escalating doses of Basis following twice daily oral administration in patients with acute kidney injury (AKI). Basis is a commercially available nutritional supplement consisting of nicotinamide riboside (NR) and pterostilbene that acts to increase sirtuin activity.
Detailed description
Acute kidney injury (AKI) is common, growing in incidence, and associated with significant morbidity and mortality. Sirtuins are anti-aging enzymes that play a diverse role in cellular energy metabolism and gene regulation. Mice deficient in SIRT1 are more susceptible to developing AKI and sirtuin activation is a potential treatment for AKI.
This is a randomized, double-blind, placebo-controlled, stepwise study of escalating doses of Basis (NR/pterostilbene) in patients with AKI. The study will potentially comprise up to four Steps. The purpose of the stepwise approach is to identify the dose of Basis that achieves at least a 50% and up to 100% increase in white blood cell (WBC) content of nicotinamide adenine dinucleotide (NAD+) without side-effects.
During each Step, Basis (5 patients) or placebo (1 patient) will be given twice a day for 2 days. Patients will have frequent blood sampling performed for a 24 hour period following dosing on Day 1 and then at 48 hr. The measurements in blood will include NR/pterostilbene blood concentrations and NAD+ and NAAD (nicotinic acid adenine dinucleotide) concentrations in WBCs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized 5 subjects in active arm (Basis) : 1 subject in control (placebo)
| Arm | Type | Receives |
|---|---|---|
| Basis | Experimental | Dietary Supplement: BasisNicotinamide riboside (NR) and pterostilbene oral capsules 250mg/50mg (Step 1) twice daily for 2 days. If the study progresses to Steps 2, 3, and 4, then 2x, 3x, and 4x the doses in Step 1 will be administered. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsules identical in appearance and number to the agent used in Steps 1-4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female hospitalized patients, age ≥ 18 years.
- Patients who have developed AKI (defined by an increase in serum creatinine by ≥0.3 mg/dL within 48 hours; or an increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior seven days).
- Adequate hematological and liver function, as assessed by the following laboratory requirements:
- Able to provide written informed consent in compliance with the Human Investigation Review Committee (IRB).
Key exclusion criteria (6 listed)
- Exposure to any investigational agent within 30 days prior to enrollment.
- Known allergy to any of the study drugs or their excipients.
- Currently pregnant (confirmed with a positive serum pregnancy test) or nursing.
- Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol.
- Baseline CKD stage 4-5 (eGFR<30 mL/minute/1.73 m2 as determined using the Modification of Diet in Renal Disease (MDRD) equation; in cases where the MDRD equation may not be suitable, a 24 hour urine creatinine clearance test may be substituted), prior to current hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BasisAlso: nicotinamide riboside (NR) and pterostilbeneNR is a form of vitamin B3; Pterostilbene is a natural dietary compound and the primary antioxidant component of blueberries | Dietary supplement | Basis |
| PlaceboPlacebo capsule(s) | Dietary supplement | Placebo |
Primary outcome
Maximum plasma concentration [Cmax] of NR
Time frame: 2 days
Maximum plasma concentration [Cmax] of NR after oral administration of Basis
Maximum plasma concentration [Cmax] of pterostilbene
Time frame: 2 days
Maximum plasma concentration [Cmax] of pterostilbene after oral administration of Basis
Area Under the Curve [AUC] of NR
Time frame: 2 days
Area Under the Curve [AUC] of NR after oral administration of Basis
Area Under the Curve [AUC] of pterostilbene
Time frame: 2 days
Area Under the Curve [AUC] of pterostilbene after oral administration of Basis
Incidence of Treatment-Emergent Adverse Events (Safety)
Time frame: 2 days
Subjects will be interviewed to determine onset of nausea, abdominal pain, vomiting, diarrhea, or rash. Adverse events will be characterized as probably related, probably not related, or unknown
Incidence of Treatment-Emergent Laboratory Abnormalities (Safety)
Time frame: 2 days
comprehensive metabolic panel (including liver function tests), complete blood count
3 secondary outcomes
NAD+ levels
Time frame: 2 days
Dose finding for 50% increase in NAD+ levels in WBCs
Time frame: 2 days
Dose finding for 100% increase in NAD+ levels in WBCs
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Derived from this study: PubMed 32791973Simic P, Vela Parada XF, Parikh SM, Dellinger R, Guarente LP, Rhee EP. Nicotinamide riboside with pterostilbene (NRPT) increases NAD+ in patients with acute kidney injury (AKI): a randomized, double-blind, placebo-controlled, stepwise safety study of escalating doses of NRPT in patients with AKI. BMC Nephrol. 2020 Aug 13;21(1):342. doi: 10.1186/s12882-020-02006-1.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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Acute Kidney Injury and Ultra-endurance Running
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Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Rhee, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basis in people with Acute Kidney Injury, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration [Cmax] of NR (time frame: 2 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03176628, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.