Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 3UH3DK114920-04S2 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
An interventional clinical trial using oral nicotinamide riboside (NR) in hospitalized patients with COVID-19 infection and acute kidney injury to determine the effect of NR on whole blood nicotinamide adenine dinucleotide (NAD+) levels and to evaluate safety of the use of NR.
The study team chose a treatment protocol with NR as a treatment for patients who will be admitted with COVID-19 related illness and develop AKI after admission. Treatment duration will be for 10 days and the primary study endpoint will be the change in whole blood NAD+ from baseline to end of treatment in NR group vs placebo group. The study team will evaluate whole blood NAD+ levels as a marker of efficacy and biological effect of NR.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Placebo capsules will be administered 2 capsules twice daily for 10 days |
|
| Nicotinamide Riboside Group | Experimental | Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo capsule containing inert ingredient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Whole Blood NAD+ Level | Measure of NAD+ level in whole blood from treatment beginning to end | Baseline to 10 days |
| Number of Participants With Adverse Events of Grade 3 or Higher | Safety of NR in hospitalized patients with COVID-19 and AKI (defined as adverse event of Grade 3 or higher). Not every grade 3 event was considered to be serious. | Baseline to 10 days |
| Occurrence of Thrombocytopenia | Number occurrences of thrombocytopenia defined as >25% decline in blood platelet count from baseline. | Baseline to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Area Under the Curve (AUC) | To determine the effect of NR on changes in AUC serum creatinine from baseline during the 10-day intervention | Baseline to 10 days |
| Effect of NR on Major Adverse Kidney Events (MAKE) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kumar Sharma, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029-6574 | United States | ||
| The University of Texas Health Science Center at San Antonio |
All collected IPD, all IPD that underlie results in a publication
At the time when summary data are published or otherwise made available
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | Placebo capsules will be administered 2 capsules twice daily for 10 days Placebo: Placebo capsule containing inert ingredient |
| FG001 | Nicotinamide Riboside Group | Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days Nicotinamide riboside: 250 mg Nicotinamide riboside capsules |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group | Placebo capsules will be administered 2 capsules twice daily for 10 days Placebo: Placebo capsule containing inert ingredient |
| BG001 | Nicotinamide Riboside Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Whole Blood NAD+ Level | Measure of NAD+ level in whole blood from treatment beginning to end | Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug. | Posted | Mean | Standard Deviation | μg/mL | Baseline to 10 days |
|
Adverse events were collected with start dates occurring any time after informed consent is obtained until Day 90 - the last visit of the study.
Adverse event severity was graded as per the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events with Grade 3, Grade 4, and Grade 5 were captured in this trial.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Group | Placebo capsules will be administered 2 capsules twice daily for 10 days Placebo: Placebo capsule containing inert ingredient |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of renal function requiring dialysis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated liver enzymes | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Subrata Debnath, Assistant Professor | University of Texas Health San Antonio | 210-450-8333 | nath@uthscsa.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2021 | Oct 16, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 22, 2021 | Feb 25, 2022 | ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
| C018613 | nicotinamide-beta-riboside |
Not provided
Not provided
Not provided
Prospective, double-blind, placebo-controlled clinical interventional trial
Not provided
Not provided
The study drug (NR or placebo) packaging and labeling will be designed to maintain the blinding of the investigator's team and the participants.
| Nicotinamide riboside | Drug | 250 mg Nicotinamide riboside capsules |
|
|
Number of occurrences of MAKE defined as doubling of serum creatinine, the initiation of long-term dialysis, or death from any cause.
| 30 days to 90 days |
| Change in Estimated Glomerular Filtration Rate (eGFR) | Measurement of change in eGFR at 30-90 days post randomization | 30 days to 90 days |
| Change in Proteinuria | Measurement of change in proteinuria at 30-90 days post randomization | 30 days to 90 days |
| San Antonio |
| Texas |
| 78229 |
| United States |
| University Health Systems | San Antonio | Texas | 78229 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days
Nicotinamide riboside: 250 mg Nicotinamide riboside capsules
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants With Adverse Events of Grade 3 or Higher | Safety of NR in hospitalized patients with COVID-19 and AKI (defined as adverse event of Grade 3 or higher). Not every grade 3 event was considered to be serious. | Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug. | Posted | Number | participants | Baseline to 10 days |
|
|
|
| Primary | Occurrence of Thrombocytopenia | Number occurrences of thrombocytopenia defined as >25% decline in blood platelet count from baseline. | Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug. | Posted | Number | participants | Baseline to 10 days |
|
|
|
| Secondary | Change in Area Under the Curve (AUC) | To determine the effect of NR on changes in AUC serum creatinine from baseline during the 10-day intervention | Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug. | Posted | Median | Inter-Quartile Range | mg/dL x day | Baseline to 10 days |
|
|
|
| Secondary | Effect of NR on Major Adverse Kidney Events (MAKE) | Number of occurrences of MAKE defined as doubling of serum creatinine, the initiation of long-term dialysis, or death from any cause. | Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug. | Posted | Number | Number of MAKE events | 30 days to 90 days |
|
|
|
| Secondary | Change in Estimated Glomerular Filtration Rate (eGFR) | Measurement of change in eGFR at 30-90 days post randomization | Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug. Limited number of participants (n <5) for whom serum creatinine values (change in estimated Glomerular Filtration Rate or eGFR) were available at 30d and 90d. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | 30 days to 90 days |
|
|
|
| Secondary | Change in Proteinuria | Measurement of change in proteinuria at 30-90 days post randomization | Analysis set is a modified intention to treat with participants receiving at least 1 dose of study drug. Proteinuria was not routinely assessed in a hospital setting for COVID patients and an additional measurement was not performed due to infectious concerns. | Posted | 30 days to 90 days |
|
|
| 6 |
| 13 |
| 7 |
| 13 |
| 6 |
| 13 |
| EG001 | Nicotinamide Riboside Group | Nicotinamide riboside 250mg capsules will be administered 2 capsules twice daily for 10 days Nicotinamide riboside: 250 mg Nicotinamide riboside capsules | 11 | 15 | 12 | 15 | 10 | 15 |
| Acute encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Heart failure | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Acute-subacute infarcts in right frontal right parasagittal and right occipital regions | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Ischemic stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypotension | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Septic shock | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cardiopulmonary arrest secondary to COVID-19 | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 24.0 | Systematic Assessment | Includes cause of death non specified in medical records and death due to: COVID-19 Pneumonia Acute respiratory failure with hypoxia Multi-organ system failure Anoxic brain injury secondary to COVID |
|
| Elevated biliruin | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Leukocytosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
|
| Superficial venous thrombosis of the mid right cephalic vein | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Occlusive deep venous thrombosis | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Delirium | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| 90-day |
|
|