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

A Phase I/II clinical trial for evaluating safety and efficacy of an innovative medicine to nephrolithiasis treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-6cf4xh

Enrollment

Unknown

Registered

2015-08-18

Start date

2016-01-04

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

nephrolithiasis

Interventions

Six male healthily volunteers will be studied in each group, randomized to receive either C. langsdorffii Standardized Extract – CSE (4 subjects) or placebo (2 subjects) in a single ascending dose pha

Drug

V03.200.100

Eligibility

Sex/Gender

Male

Age

18 Years to 55 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Brazil

Contacts

Public ContactEduardo Coelho

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

ebcoelho@fmrp.usp.br+55(16)3602-2543

Outcome results

None listed

Source: REBEC (via WHO ICTRP)