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

May 22, 2026 updated by: Amar h Zireg
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
    • Wilaya de Bordj Bou Arréridj
      • Bordj Bou Arreridj, Wilaya de Bordj Bou Arréridj, Algeria, 34000
        • Amar hocine Zireg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and every month for to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and every 3 months for 6 months
Incidence of Treatment-Emergent Adverse Events
Time Frame: 12 months.
Safety monitoring of the GRAS-based oral protocol throughout the observation period.
12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amar h Zireg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Actual)

April 15, 2026

Study Completion (Actual)

May 19, 2026

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Amarzireg

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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