Clinical Observation of Renal Function Reactivation Following a GRAS-Based Protocol in Patients With Chronic Kidney Disease and Long-Term Renal Arrest.

Amar h Zireg8 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic Nephropathy Anuria End-Stage Renal Disease (ESRD)Chronic Kidney Disease, Stage 5

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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: * Aged 18 and older" et "Diagnosed with ESRD (End-Stage Renal Disease)". Exclusion Criteria: * Pregnant women

Outcomes

Primary Outcomes

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).

Time frame: Baseline and every month for to 6 months

Secondary Outcomes

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.

Time frame: Baseline and every 3 months for 6 months

Incidence of Treatment-Emergent Adverse Events

Safety monitoring of the GRAS-based oral protocol throughout the observation period.

Time frame: 12 months.