Study to evaluate the efficacy and safety of Renochlor Tablets in patients with chronic kidney disease

Multicentric, Prospective, Randomized Case Control study to evaluate the efficacy and safety of Renochlor Tablets in patients with chronic kidney disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/11/047560

Enrollment

300

Registered

2022-11-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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)

Interventions

Intervention1: RENOCHLOR 40mg Tablet (Sodium Copper Chlorophyllin) and standard care of treatment: 40mg Tablet 3 times a day for 9 months along with standard care Control Intervention1: Standard Care

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed cases of chronic kidney disease (CKD) in stage G1 to G4 and A1 to A4. 2. Male and Female, Age more than 18 years and less than 80 years.

Exclusion criteria

Exclusion criteria: 1.Patients with severe and end stage CKD as per Investigator discretion. 2.Not willing to participate. 3.Pregnant or lactating Women 4.Not likely to follow up for 09 months.

Design outcomes

Primary

Measure	Time frame
Change from baseline in eGFRTimepoint: Day 0, Day 90, 180 and 270	—

Secondary

Measure	Time frame
Change in Albumin-to-creatinine ratio (ACR)Timepoint: Day 0, Day 90, 180 and 270;Change in BUN and Serum AlbuminTimepoint: Day 0, Day 90, 180 and 270;Change in electrolytes (Sodium and Potassium)Timepoint: Day 0 and Day 270;Change in Serum CreatinineTimepoint: Day 0, Day 90, 180 and 270;Incidence rates of AE/SAE including changes in laboratory parametersTimepoint: Day 0, Day 90, 180 and 270;Kidney Disease Quality of Life (KDQOL-SFTM) Version 1.3Timepoint: Day 0, Day 90, 180 and 270	—

Measure

Time frame

Change in Albumin-to-creatinine ratio (ACR)Timepoint: Day 0, Day 90, 180 and 270;Change in BUN and Serum AlbuminTimepoint: Day 0, Day 90, 180 and 270;Change in electrolytes (Sodium and Potassium)Timepoint: Day 0 and Day 270;Change in Serum CreatinineTimepoint: Day 0, Day 90, 180 and 270;Incidence rates of AE/SAE including changes in laboratory parametersTimepoint: Day 0, Day 90, 180 and 270;Kidney Disease Quality of Life (KDQOL-SFTM) Version 1.3Timepoint: Day 0, Day 90, 180 and 270

—

Countries

India

Contacts

Public ContactSanjay Vekariya

THINQ Pharma-CRO Ltd.

srini@thinqcro.com912225816800

Outcome results

None listed

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