End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic NephropathyNCT07555327
Clinical Observation of Renal Function Reactivation Following a GRAS-Based Protocol in Patients With Chronic Kidney Disease and Long-Term Renal Arrest.
An observational study of End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic Nephropathy and Anuria, run by Amar h Zireg at 1 site in Algeria.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic Nephropathy, Anuria, End-Stage Renal Disease (ESRD)
- What is being tested?
- CSR-CKD Oral Protocol
- Type of treatment
- Pill or oral medicine
- How many people
- 8 participants
- Where
- 1 siteAlgeria
- Study dates
- 2 Feb 2026to 19 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Child, Adult, Older adult
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
Who may be able to join
None listed.
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Algeria1 site
Amar hocine Zireg
Bordj Bou Arreridj, Wilaya de Bordj Bou Arréridj, 34000
About this study
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.
Read the 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.
- Conditions
- End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic Nephropathy, Anuria, End-Stage Renal Disease (ESRD), Chronic Kidney Disease, Stage 5, Renal Regeneration, Diabetes
- Being tested
- CSR-CKD Oral Protocol
- Keywords
- Renal Reactivation, Kidney Regeneration, Chronic Kidney Disease Stage 5, Hemodialysis Recovery, Anuria Reversal, GRAS Protocol, Limb Salvage Platform, Diabetic Nephropathy Recovery
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Anuria, Diabetes Mellitus, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSR-CKD Oral ProtocolDietary 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and every month for to 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start2 Feb 2026
- Primary completion15 Apr 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amar h Zireg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amar h Zireg, Amar Zireg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555327
- Sponsor's protocol ID
- Amarzireg
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Renal Function Reactivation Following a GRAS-Based Protocol in Patients With Chronic Kidney Disease and Long-Term Renal Arrest.
- ClinicalTrials.gov ID
- NCT07555327
- Acronym / sponsor ID
- Amarzireg
- Conditions
- End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic Nephropathy, Anuria, End-Stage Renal Disease (ESRD), Chronic Kidney Disease, Stage 5, Renal Regeneration, Diabetes
- Keywords
- Renal Reactivation, Kidney Regeneration, Chronic Kidney Disease Stage 5, Hemodialysis Recovery, Anuria Reversal, GRAS Protocol, Limb Salvage Platform, Diabetic Nephropathy Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Amar h ZiregUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSR-CKD Oral ProtocolA 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. | Dietary supplement | – |
Primary outcome
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).
2 secondary outcomes
Elimination of Chronic Diabetic Fatigue
Time frame: Baseline and every 3 months for 6 months
Incidence of Treatment-Emergent Adverse Events
Time frame: 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-Stage Renal Disease (ESRD) Chronic Kidney Disease, Stage 5 Renal Regeneration Anuria Diabetic Nephropathy and Anuria, run by Amar h Zireg at 1 site in Algeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Algeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Daily Urine Output Volume (time frame: Baseline and every month for to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.