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Cease Chronic Kidney Disease

A Prospective, Open label Randomised Trial to Assess the Safety and Efficacy in Enzobiotics & Finerenone in CKD Patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/092042
Enrollment
210
Registered
2025-07-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: N181- Chronic kidney disease, stage 1 Health Condition 2: N182- Chronic kidney disease, stage 2 (mild) Health Condition 3: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 4: N184- Chronic kidney disease, stage 4 (severe) Health Condition 5: N185- Chronic kidney disease, stage 5

Interventions

Intervention1: Enzobiotics: Enzobiotics - a combination of Synbiotic and Proteolytic enzyme is clinically proven and provides significant benefits in controlling protein bound uremic toxins, PCS and I

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects aged between 18 - 70yrs 2. Stage 1 to Stage 5 with CKD. 3. Patient wanting to delay dialysis 4. Willing to come for regular follow-up visits 5. Able to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactation. 2. Autoimmune disease e.g. SLE or Vasculities. 3. Subjects with hepatic impairement (SGOT or SGPT levels greater than 3 times the upper limit). 4. Diabetic foot infection patients. 5. Subjects with uncontrolled cardiovascular events. 6. Patients on other Pre-Probiotic therapy and with enzymes 7. Patients with acute coronary syndrome. 8. Patients who have been prescribed Synbiotics and Enzymes 9. Subjects with any other severe systemic illness and in the opinion of the investigator would be non-compliant with the visit schedule or study procedures.

Design outcomes

Primary

MeasureTime frame
1. Assess Safety and Efficacy of Enzobiotics & Enzobiotics in combination with Finerenone in CKD Stage 1 - Stage 5 Patients. 2. Retardation of CKD Progression 3. Slope of eGFR (Cockgrauft or MDRD ) and uACRTimepoint: 180 Days Trial, Follow-up 365 days—

Secondary

MeasureTime frame
Change in BUN, Creatinine, Hemoglobin, Phosphorous, Potassium, Sodium , Albumin serum, Urea, Ferritin, Total Protein, Triglycerides Total cholesterol, HDL, LDL, Hepcidin, Hospitalization during study period, CRP, CBC and in vitals Heart rate, Change in Proteinuria ,IL-6, Insulin Resistance, UPCR, Patient Reported outcome SF36 Change in P-Cresols and Indoxyl sulfate, Protein bound Uremic toxins levels based on EETOX study equationTimepoint: Day 1, Day 90, Day 180—

Countries

India

Contacts

Public ContactDr Indranil Ghosh

Army Hospital Research and Referral

rajpro_5@yahoo.com9876268895

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026