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This observational study documents the impact of a specific oral protocol (based on FDA-GRAS ingredients) on patients with Stage 5 Chronic Kidney Disease (CKD). The study observes 8 participants, including 6 with residual renal function and 2 patients with long-term total renal arrest (16 years and 22 years of anuria). The primary focus is monitoring the restoration of urine output and changes in renal biological markers.
This study follows 8 patients categorized into two sub-groups:
Sub-group A (6 patients): Individuals with residual urine output at baseline. Sub-group B (2 patients): Individuals in total renal arrest on long-term hemodialysis.
Case 1: Diabetic patient with 16 years of renal arrest. Case 2: Non-diabetic patient with 22 years of renal arrest.
All participants self-administered an oral protocol of GRAS-certified nutritional components. The investigators observed clinical outcomes over a 12-month period, focusing on the reactivation of dormant renal tissue and the evolution of filtration capacity.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSR-CKD Oral Protocol | Dietary Supplement | A specific oral nutritional intervention consisting of synergistic FDA-GRAS (Generally Recognized As Safe) components designed to support renal tissue recovery and restoration of urine output. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Urine Output Volume | Evaluation of the restoration of renal secretory function. We specifically monitor the transition from total anuria (0 mL/day) to a functional state (targeting a recovery of 3% to 6% of normal urine output volume or more). | Baseline and every month for to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Elimination of Chronic Diabetic Fatigue | Assessment of patient energy levels and the reduction of chronic fatigue associated with CKD and Diabetes through a standardized quality-of-life questionnaire. | Baseline and every 3 months for 6 months |
| Incidence of Treatment-Emergent Adverse Events |
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Sampling Method: Non-Probability Sample
Criteria: Patients with confirmed Stage 5 CKD on or off dialysis, with documented periods of renal inactivity ranging from residual function to 20+ years of total arrest.ion Criteria:
Exclusion Criteria:
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The study population consists of a specific cohort of 8 adult patients (diabetic and non-diabetic) diagnosed with Stage 5 Chronic Kidney Disease (CKD). The group is characterized by a wide spectrum of renal impairment, ranging from patients with residual urine output to individuals in total renal arrest on long-term hemodialysis. A key feature of this population is the inclusion of patients with extreme periods of anuria, specifically documenting cases of 16 years and 22 years of total renal inactivity prior to the observation period
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amar hocine Zireg | Bordj Bou Arreridj | Wilaya de Bordj Bou Arréridj | 34000 | Algeria |
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Safety monitoring of the GRAS-based oral protocol throughout the observation period. |
| 12 months. |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| D001002 | Anuria |
| D003920 | Diabetes Mellitus |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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