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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07555327

Enrollment

Registered

2026-04-29

Start date

2026-02-02

Completion date

2026-05-19

Last updated

2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anuria, Chronic Kidney Disease, Stage 5, Diabetes, Diabetes Complications, Diabetes Mellitus ( Type 1 and Type 2), End-Stage Renal Disease (ESRD), End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic Nephropathy, Non Diabetic Patients, Renal Regeneration

Keywords

Renal Reactivation, Kidney Regeneration, Chronic Kidney Disease Stage 5, Hemodialysis Recovery, Anuria Reversal, GRAS Protocol, Limb Salvage Platform, Diabetic Nephropathy Recovery

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTCSR-CKD Oral Protocol

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Daily Urine Output Volume	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

Measure	Time frame	Description
Elimination of Chronic Diabetic Fatigue	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	12 months.	Safety monitoring of the GRAS-based oral protocol throughout the observation period.

Countries

Algeria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026