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Chronic kidney disease CKD is estimated to affect nearly over 800 million people globally today (with roughly 125,000 people ending up annually on dialysis in the United States alone. CKD is a contributor to illness and is associated with a diminished quality of life and reduced life expectancy . In this study the investigators are using a novel drug to target improved function of the kidneys.
Chronic kidney disease has been linked to impaired activity of mitochondrial dysfunction along with oxidative intracellular mechanisms that result in the cascade of progressive damage within renal tubular cells. Several treatment options for mitochondrial dysfunction have been suggested to target the loss of nephrons via renal fibrosis and tubular senescence of the kidney cells by enhancing the mitochondrial activity of these cells via the NAD/NAD+ redox pathway as well as reduce the presence of fibrogenic intracellular inflammatory markers .
QRX-3 is a formulated novel drug designed to supply and optimize NAD+ mitochondrial availability and prevent this nephron loss .
In this study the investigators will evaluate the effect of intervention with this novel drug therapy on chronic kidney disease CKD population with slowly declining renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Active Comparator | QRX-3 - two capsules orally twice daily |
|
| placebo | Placebo Comparator | placebo pill - one capsule orally twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QRX-3 | Drug | capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in Glomerular filtration rate | change percentage in kidney function level measured with cystatin creatinine glomerular filtration rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| change in Proteinuria | change in random urine protein/creatinine ratio | 1 year |
| change in rate of Glomerular filtration rate decline | comparism of slopes of decline in cystatin creatinine glomerular filtrate rate |
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Inclusion Criteria:
Inclusion criteria
Exclusion Criteria:
Rapid rate of decline in kidney function of > 20 % over last one year
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neukidney Inc | Pasedena | Texas | 77504 | United States |
de-identified information of each participants trial characteristics will be available for sharing
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D058186 | Acute Kidney Injury |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Randomized placebo double control
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placebo arm with intervention pill arm
| 1 year |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |