An observational study in End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic Nephropathy, Anuria and End-Stage Renal Disease (ESRD), sponsored by Amar h Zireg. Completed at 1 site in Algeria. Open to male participants. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Amar h Zireg · Observational
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 8 is below the median of 120 across 442 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Amar h Zireg is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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:
Exclusion Criteria:
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.
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
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.
Ran from Feb 2026 to primary completion in Apr 2026, 2 months.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Amar h Zireg