Phase IV clinical trial of Renadyl in the patients of stage III and IV Chronic Kidney Disease (CKD).

Prospective, Open-label, Multicentric, Phase IV study to substantiate the Safety and Efficacy of Renadyl in the patients of stage III and IV of Chronic Kidney Disease (CKD).

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/03/024198

Enrollment

200

Registered

2020-03-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe)

Interventions

Intervention1: Renadyl, each capsule contains 45 Billion CFU of Streptococcus thermophilus (KB19), Lactobacillus acidophilus (KB27) and Bifidobacterium longum (KB31): 1 capsule B.I.D. for 180 days Con

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients of stage III and IV chronic kidney disease (GFR from 15-59mL/min per 1.73 m2) 2) Willing to sign on informed consent form 3) Patients who can adhere to the Protocol

Exclusion criteria

Exclusion criteria: 1) Patients known, or thought to be hypersensitivity to 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

Measure	Time frame
Primary Efficacy Parameters: 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

Measure	Time frame
Secondary Efficacy Parameters: 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 ContactDr Mayuresh D Kiran

Centaur Pharmaceuticals Pvt Ltd

lalit@centaurlab.com02267609341

Outcome results

None listed

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