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Low Protein Diet Supplementation Study in Non-Diabetic Kidney Disease Patients

A Randomized, Open Label, Three Arm, Comparative, Controlled, Single-center Study to Evaluate the Effect of Low Protein Diet Supplementation with Taurine and N-Acetylcysteine (Tab. Nefrosave) and N-Acetylcysteine and Pyridoxamine Dihydrochloride (Tab. Nefrosave Forte) in Preventing Progression of Chronic Renal Failure in Patients with Non-Diabetic Kidney Disease.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008246
Enrollment
75
Registered
2017-03-29
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: null- Non-Diabetic Kidney Disease

Interventions

Intervention1: Low protein diet supplemented with (Taurine (500 mg) and N-Acetylcysteine (150 mg)) tablet: Low protein diet (0.6g of proteins per kilo of body weight per day) supplemented with Nefrosa
Route: Oral
Frequency: One tablet twice daily
Duration of Therapy: 6 Months Intervention2: Low protein diet supplemented with (N-Acetylcysteine (300 mg) and Pyridoxamine Dihydrochloride (50 mg)) tablet: Low protein diet (0.6g of proteins per kilo
Duration of Therapy: 6 Months Control Intervention1: Low protein diet: Low protein diet (0.6g of proteins per kilo of body weight per day)
Route: Any Route
Frequency: Per day 0.6 g of Protein per kilo of body weight during three meals a day
Duration of Therapy: 6 Months

Sponsors

Dr Pratim Sengupta
Lead Sponsor
QASCENT RESEARCH SOLUTIONS PVT LTD
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1)Ability to understand and provide informed consent for participation in the study 2)Males or females >=18 or 3)Chronic renal failure patients with GFR more than 15 ml/min/1.73m2 and less than 60ml/min/1.73m2 receiving standard of care based on investigatorâ??s discretion 4)Life expectancy greater than one year 5)Non diabetic patients 6)Well controlled blood pressure (MAP

Exclusion criteria

Exclusion criteria: 1)Patient incapable of following study requirement to control diet 2)Patient with ongoing acute inflammation or AKI 3)Patients maintained on dialysis 4)Patient anticipating for kidney transplant within next 6 months, or those who had a kidney transplant 5)Proteinuria >10gm/day 6)Hb 16g/dl 7)BMI 30 kg/m2 8)Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from Day 1 until the month 6 visit 9)Participation in other product clinical trial within 30 daysâ?? prior to this trial 10)Any other systemic disease or any other abnormal laboratory values which as per investigator will interfere with patientâ??s participation in study

Design outcomes

Primary

MeasureTime frame
The rate of change of GFR (Slope)Timepoint: Month 3—

Secondary

MeasureTime frame
eGFR will be calculated by MDRD formulaTimepoint: Month 1, Month 2, Month 3, Month 4, Month 5 and Month 6;Measurement of serum creatinine after 8 hours fastTimepoint: Month 1, Month 2, Month 3, Month 4, Month 5 and Month 6;Urinary creatinine clearanceTimepoint: Month 3 and Month 6—

Countries

India

Contacts

Public ContactSubhash Sugathan

Belle Vue Clinic

Pratim.sengupta@gmail.com09830099686

Outcome results

None listed

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