Global Phase 2 clinical trial to Evaluate Safety And Efficacy Of US-APR2020 In Subjects WithChronic Kidney Disease Stage IV

An Open-Label Rollover Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of US-APR2020 in Subjects With CKD IV Who Completed the US-APR2020-01 Study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057401

Enrollment

600

Registered

2023-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Health Condition 1: N184- Chronic kidney disease, stage 4 (severe)

Interventions

Intervention1: US-APR2020: Live Bio Therapeutic Product containing a mix of Streptococcus thermophilus (KB19), Lactobacillus acidophilus(KB27) and Bifidobacterium longum (KB31) Duration of the trial i

Eligibility

Inclusion criteria

Inclusion criteria: Completion of US-APR2020-01 study Adults between the ages of 18–80 years

Exclusion criteria

Exclusion criteria: Did not participate in the placebo-controlled study US-APR2020-01 Withdrew from US-APR2020-01 study prior to completing the 6 months treatment for any reason Unwilling or unable to visit the site for the follow-up visits.

Design outcomes

Primary

Measure	Time frame
Evaluate the long-term safety & clinical efficacy of US-APR2020 in patients with Chronic Kidney Disease (CKD) Stage IV.Timepoint: US-APR2020 or placebo will be administered orally at 2 capsules per day (one capsule in the morning & one capsule in the evening, after meals, for a total daily dose of 90 Billion CFUs).Subjects will be followed for 6 months. Visit 1 at Day 1, Visit 2 at Day 60, Visit 3 at day 120 & Visit 4 at day 180	—

Measure

Time frame

Evaluate the long-term safety & clinical efficacy of US-APR2020 in patients with Chronic Kidney Disease (CKD) Stage IV.Timepoint: US-APR2020 or placebo will be administered orally at 2 capsules per day (one capsule in the morning & one capsule in the evening, after meals, for a total daily dose of 90 Billion CFUs).Subjects will be followed for 6 months. Visit 1 at Day 1, Visit 2 at Day 60, Visit 3 at day 120 & Visit 4 at day 180

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Secondary

Measure	Time frame
Evaluate changes in basic blood uremic metabolic markers Evaluate changes in complete blood count & hematology parameters Evaluate changes in C-Reactive Protein (CRP) levels Quantify improvement in quality of life (QOL)Timepoint: US-APR2020 or placebo will be administered orally at 2 capsules per day (one capsule in the morning & one capsule in the evening, after meals, for a total daily dose of 90 Billion CFUs).Subjects will be followed for 6 months. Visit 1 at Day 1, Visit 2 at Day 60, Visit 3 at day 120 & Visit 4 at day 180	—

Measure

Time frame

Evaluate changes in basic blood uremic metabolic markers Evaluate changes in complete blood count & hematology parameters Evaluate changes in C-Reactive Protein (CRP) levels Quantify improvement in quality of life (QOL)Timepoint: US-APR2020 or placebo will be administered orally at 2 capsules per day (one capsule in the morning & one capsule in the evening, after meals, for a total daily dose of 90 Billion CFUs).Subjects will be followed for 6 months. Visit 1 at Day 1, Visit 2 at Day 60, Visit 3 at day 120 & Visit 4 at day 180

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Countries

Argentina, India, United States of America

Contacts

Public ContactDr Mukund Zarapkar

LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt.Ltd.

drzarapkar@lifesan.in912266499154

Outcome results

None listed

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