MedPath

RenoDiet-HP in Chronic Kidney Disease Patients Undergoing Maintenance Hemodialysis

Phase 2
Conditions
Health Condition 1: N189- Chronic kidney disease, unspecified
Registration Number
CTRI/2020/12/030086
Lead Sponsor
Pulse Pharmaceuticals Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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