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

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.

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Key information

Conditions

End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic Nephropathy Anuria Chronic Disease Chronic Kidney Disease, Stage 5 Diabetes Diabetes Complications Diabetes Mellitus Diabetes Mellitus ( Type 1 and Type 2) Disease Attributes End-stage Renal Disease (ESRD) Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Non Diabetic Patients Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Renal Regeneration Urination Disorders Urogenital Diseases Urologic Diseases

Sex eligibility

Male

Study type

Observational

Primary location

Amar hocine Zireg

Bordj Bou Arreridj, Wilaya de Bordj Bou Arréridj, 34000, Algeria

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Change in Daily Urine Output Volume

Time frame: Baseline and every month for to 6 months

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).

Secondary outcomes

Elimination of Chronic Diabetic Fatigue

Time frame: Baseline and every 3 months for 6 months

Assessment of patient energy levels and the reduction of chronic fatigue associated with CKD and Diabetes through a standardized quality-of-life questionnaire.
Incidence of Treatment-Emergent Adverse Events

Time frame: 12 months.

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

Sponsors and collaborators

Lead sponsor

Amar h Zireg

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Apr 29, 2026
Registry last updated: May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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