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

NCT07555327 | Active Not Recruiting

• 1 other identifier: Amarzireg
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Elimination of Chronic Diabetic Fatigue

  Baseline and every 3 months for 6 months

• Incidence of Treatment-Emergent Adverse Events

  12 months.

Interventions

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.

Eligibility Criteria

• Sex: male
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• Amar h Zireg: lead

Study Sites (1)

Amar hocine Zireg

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

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Anuria

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator,

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 29, 2026
• Study Start: February 2, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

AL (1)