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RenoDiet-HP in Chronic Kidney Disease Patients Undergoing Maintenance Hemodialysis

Safety and Efficacy of Oral Nutritional Supplement (RenoDiet-HP) in Patients with Chronic Kidney Disease Undergoing Maintenance Haemodialysis - RenoDiet-HP in CKD

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/030086
Enrollment
60
Registered
2020-12-29
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: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: RENODIET-HP: Oral Nutritional Supplement (RenoDiet-HP) 32g in 65ml of normal water twice daily Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Sponsors

Pulse Pharmaceuticals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All consenting patients with CKD, above 18 years of age, and receiving twice or thrice weekly maintenance hemodialysis for atleast 6 months at the outpatient hemodialysis unit will be included in the study. 2. Patients willing to sign the Informed Consent Form (ICF).

Exclusion criteria

Exclusion criteria: 1. Patients with intercurrent acute illnesses. 2. Bodyweight less than 40 kg. 3. Documented history of dialysis non-compliance. 4. Documented malabsorption syndrome. 5. Contraindications to any ingredient of RenoDiet-HP. 6. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. (Chronic illness may include but is not limited to, cardiac, renal, autoimmune, hepatic, haematological, genetic disorders, atopic conditions, congenital defects, diabetes, convulsions or encephalopathy, tuberculosis etc.). 7. Pregnant & Lactating women. 8. Patients who are not willing to sign the ICF.

Design outcomes

Primary

MeasureTime frame
To assess any changes in the levels of serum albumin, haemoglobin, phosphorus, potassium, and total iron-binding capacity (TIBC), and body weight after treating with RenoDiet-HP for 03 months.Timepoint: 3 MONTHS

Secondary

MeasureTime frame
To assess the Malnutrition Inflammation Score (MIS) & Subjective Global Assessment (SGA).Timepoint: 3 MONTHS

Countries

India

Contacts

Public ContactDr Geeta Sheth

Sir Jamshedjee Jeejeebhoy Group of Hospital

dr.geetasheth@yahoo.com9870735192

Outcome results

None listed

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