A preliminary study for testing a new drug to kidney stones treatment

Phase 1

• Conditions: nephrolithiasis; N20.9; C12.777.419.600

• Registration Number: RBR-6cf4xh
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

18 to 55 years old; male; any race, healthy volunteers; non-smoking; without drug addiction, use of alcohol or medicines.

Exclusion Criteria

Female; elderly (age>55years); any clinically detectable disease, found on clinical history or physical examination; abnormal ECG (except unspecific ventricular repolarization changes, sinus brady/tachycardia); abnormal laboratory tests in blood cells count, kidney, reproductive, metabolic or hepatic function; participation in clinical trials in the last year; history of allergic reaction to medicines; use of any drug one week before the beginning or during the study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main outcome will be the absence of occurrence of serious adverse event. Laboratory tests for acute renal injury (creatinin and injury tubular markers Ngal, NAG, KIM-1 and alfa1 microglobulin); acute liver injury (SGOT, SGPT, gama-GT,blirubins, alkaline phosphatase); cardiac damage (measurement of QT and QTc value on ECG); hematologic toxicity (Hb, Ht, white blood cells, platelets); reproductive toxicity (espermogram, inhibin-B, FSH, LH, testosterone) and metabolic changes (glucose and lipidrogram) will be compared after and before the administration of C. langsdorffii Standardized Extract. Clinical signs and symptoms eventually reported by subjects of study will be recorded.

Secondary Outcome Measures

Name	Time	Method
Change of urinary biochemical parameters to non-lithogenic pattern. The concentration of pro-lithogenic elements (calcium, uric acid, oxalate, phosphate and pH) and inhibitors of stone formation (citrate and magnesium) will be measured in 24h urine samples before and after the administration of C. langsdorffii Standardized Extract.