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Evaluating Renadyl s Safety and Efficacy in Chronic Kidney Disease Patients.

Observational Post Marketing Surveillance Study To Substantiate the Safety And Efficacy of Renadyl in the Patients of Stage III And IV of Chronic Kidney Disease (CKD) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/07/091914
Enrollment
20
Registered
2025-07-28
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: N184- Chronic kidney disease, stage 4 (severe) Health Condition 2: N183- Chronic kidney disease, stage 3 (moderate)

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil Intervention4: Renadyl: Renadyl, each capsule contains 45 Billion CFU of Streptococcus thermophilus (KB19), Lactobacillus acidop

Sponsors

Centaur Pharmaceuticals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.]Ages: 18-75 years 2.]Gender eligible for Study: both Males and Females 3.]Patients of stage III and IV chronic kidney disease (GFR from 15-59mL/min per 1.73 m2) 4.]Willing to sign on the informed consent form 5.]Patients who can adhere to the Protocol

Exclusion criteria

Exclusion criteria: 1.]Patients known to be hypersensitive to the study product 2.]Patients on dialysis or have undergone dialysis in the past 3.]Pregnant or Lactating Women 4.]HIV/AIDs and Liver disease patients 5.]Antibiotic treatment at the time of screening or within 30 days before screening 6.]Immunosuppressive treatment at the time of screening or within 90 days before screening 7.]Patients suffering from Irritable Bowel Syndrome, Inflammatory Bowel Disease and patients who have undergone resection surgeries of the GI tract 8.]Patients with CKD due to obstructive uropathy and ADPKD 9.]Patients having severe cardiac arrhythmias and grade III & IV (NYHA classification) of CHF 10.]Patients with active dependency on drugs/alcohol for the last 12 months 11.]Patients having history of taking any probiotic for 3 months at the time of screening 12.]Patients who cannot adhere to the Protocol (Mentally Ill and Patients with Psychological problem)

Design outcomes

Primary

MeasureTime frame
1. Reduction in Serum Creatinine Level 2. Reduction in Blood Urea Nitrogen (BUN) Level 3. Reduction in Serum Urea Level 4. Reduction in Serum Uric Acid LevelTimepoint: At day 1, day 90 and day 180—

Secondary

MeasureTime frame
1.Elevation in Creatinine Clearance 2. Elevation in estimated Glomerular Filtration Rate (eGFR) 3. Complete Blood Count (CBC)Timepoint: At day 1, day 90 and day 180—

Countries

India

Contacts

Public ContactMs Aakansha Singh

Centaur Pharmaceuticals Pvt Ltd

pramita@centaurlab.com02267609341

Outcome results

None listed

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