Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2021
• Main ID: NCT04695951
• Date of registration: 15/12/2020
• Prospective Registration: No
• Primary sponsor: Catalysis SL
• Public title: Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract
• Scientific title: Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract
• Date of first enrolment: August 1, 2019
• Target sample size: 155
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04695951
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 2

Countries of recruitment

Nicaragua

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient over 18 years of age, in all their mental and physical capacities to decide to
be part of this study.

2. There are no comorbidities or associated diseases that put the stability of the
patient at risk.

3. Not be diagnosed as Chronic Kidney Disease, in any stage.

4. Existence of non-obstructive stones smaller than 10 mm located in the renoureteral
path.

5. No compromise of renal viability.

Exclusion Criteria:

1. Patients under 18 years of age.

2. Existence of comorbidities or associated diseases that put the stability of the
patient at risk.

3. Existence of a diagnosis of Chronic Kidney Disease, at any stage.

4. Presence of non-obstructive or obstructive stones greater than 10 mm located in the
renoureteral path.

5. Renal viability compromise.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Disease

Ureteral Obstruction

Urolithiasis

Kidney Injury

Ureteral Injury

Urolithiasis, Calcium Oxalate

Urolithiasis; Lower Urinary Tract

Renal Injury

Kidney Calculi

Renal Stone

Ureteral Calculi

Intervention(s)

Dietary Supplement: Renalof

Other: Placebo

Primary Outcome(s)

kidney stone clearance with Renalof® treatment compared to placebo [Time Frame: 4 months]

Secondary Outcome(s)

Adverse events related with product of the trial [Time Frame: 4 months]

Quality of life of patients [Time Frame: 4 months]

Number of colic [Time Frame: 4 months]

Secondary ID(s)

201920-RENALOF-NI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors