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Nephrolithiasis clinical trials

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NCT ID: NCT04495608 Active, not recruiting - Nephrolithiasis Clinical Trials

Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels

FLUCOLITH
Start date: January 13, 2021
Phase: Phase 2
Study type: Interventional

Hypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis leading to Chronic Kidney Disease (CKD) and bone complications in adults. Hypercalciuria can be secondary to increased intestinal absorption and/or increased renal distal tubular reabsorption of calcium due to increased active vitamin D, i.e. 1,25(OH)2D, levels. The management of hypercalciuria is challenging. Classic management based on hyperhydration and dietary advice has low impact on calciuria and therefore on CKD progression. Other strategies such as hydrochlorothiazide can be proposed, however with an uncertain medical benefit in view of side effects (hypokalemia, asthenia, potential cutaneous long-term side effects). Azoles are known to inhibit the 1α-hydroxylase and therefore decrease 1,25(OH)2D levels. These antifungal drugs are commonly used in neonates, infants and adults; pharmacokinetic data are well described. Recently, to improve azoles tolerance, fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 mutation (1 adult) or NPTIIc mutations (1 child), while maintaining a stable renal function. Based on these observations, the investigators hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH)2D levels. The primary objective is to demonstrate that fluconazole normalizes or decreases calciuria after 18 weeks of treatment in patients with hypercalciuria and increased 1,25(OH)2D levels. The secondary objectives aim to describe: - the effects of fluconazole on the evolution over time of the calcium/phosphate metabolism, - the evolution of renal function, - the cohort at Baseline and after 4 months of treatment period, - the safety of fluconazole, - the onset of potential mycological resistances, - and the treatment compliance. This is a prospective, interventional, national, randomized in 2 parallel groups (1:1), controlled versus placebo, double blind trial. This study will involve patients between 10 and 60 years of age suffering from nephrolithiasis and/or nephrocalcinosis with hypercalciuria (> 0.1 mmol/kg/d) and increased 1,25 (OH)2D levels (≥ 150 pmol/l) and 25-OH-D levels (≥50 nmol/L). FLUCOLITH study is a unique opportunity to develop a new indication of a well-known and not expensive drug (e.g. fluconazole) in rare renal diseases, the ultimate objective being the secondary prevention of CKD worsening in these patients. If the results of this proof-of-concept randomized controlled trial are positive, the investigators will propose an extension phase to evaluate the long term efficacy and safety of fluconazole on renal and bone parameters.

NCT ID: NCT04438551 Withdrawn - Kidney Stone Clinical Trials

Software Application for Low-Sodium Diet Trial (SALT)

Start date: February 12, 2021
Phase: N/A
Study type: Interventional

This a single-center prospective randomized controlled trial. Subjects will be assigned to the standard of care dietary recommendations for a low sodium diet (LSD) vs. the standard of care dietary recommendations for a low sodium diet plus a mobile application that analyzes sodium content of shopping lists that are created prior to shopping trips to the grocery store over an 8-week study period. An initial pilot phase will be done to ensure adequate percentage of subjects are completing the study in the intervention group and that adequate data is being collected.

NCT ID: NCT04430426 Not yet recruiting - Kidney Stone Clinical Trials

Heterozygous Individuals for AGXT and Kidney Stones

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This study seeks to examine the effects of a heterozygous mutation of the AGXT gene in a stone forming population on endogenous oxalate production. Participants will consume a controlled low-oxalate diet and provide blood and urine samples to measure the amount of oxalate in their bodies. Subjects will then be administered an intravenous (IV) load of glycolate, providing additional blood and urine samples afterwards to measure any increase in oxalate levels.

NCT ID: NCT04404855 Completed - Kidney Stone Clinical Trials

Antibiotic Selection Using Next Generation Sequencing vs Urine Culture

ACCESS
Start date: December 18, 2019
Phase: N/A
Study type: Interventional

This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy.

NCT ID: NCT04389853 Recruiting - Kidney Stone Clinical Trials

Mini-PNCL vs fURS in Management of Nephrolithiasis

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

The prevalence of nephrolithiasis is increasing over the last two decades, and kidney stones is a recurrent disorder, with lifetime recurrence risks reported to be as high as 50%. One of the most challenging stones is the lower pole (LP) nephrolithiasis. The standard management of lower pole stones (LPS), is still controversial especially for stones smaller than 20 mm, with retrograde intrarenal surgery (RIRS) and mini-PCNL (miniperc) both demonstrated to be safe and effective methods for treating LPS with a diameter of 1-2 cm. Selecting the optimal modality for treating renal calculi is challenging, as both techniques may be associated with different patient benefits and risk profiles. Despite the evolution of mini-PCNL and fURS techniques into clinical practice, there is a lack of comparative clinical data assessing SFRs and complication rates. To the investigators' knowledge, no previous studies have addressed the outcome of ambulatory tubeless miniperc as a same day procedure, which this study will look to assess. The investigators are planning to discharge all participants home the night of surgery, without admission or insertion of nephrostomy tube. This will decrease the morbidity of miniperc and encourage head-to-head comparison with fURS in a prospective randomized protocol.

NCT ID: NCT04374188 Recruiting - Nephrolithiasis Clinical Trials

Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.

NCT ID: NCT04370093 Recruiting - Clinical trials for Nephrolithiasis, Uric Acid

Pathogenesis of Uric Acid Nephrolithiasis: Role of Pioglitazone/Weight Loss

Start date: October 17, 2019
Phase: Phase 4
Study type: Interventional

The investigators will randomize overweight and obese iuan patients to Pio (45 mg/day, highest approved dose or placebo), WL (10% of body weight, following the established program used in the Diabetes Prevention Program), or Pio+WL. Participants will be evaluated at baseline and after 24 weeks of intervention while on a fixed metabolic diet to exclude the confounding effects of diet and perspiration. The primary endpoint will be change in upH, and multiple additional endpoints (serum, urine, imaging) will be assessed.

NCT ID: NCT04367155 Recruiting - Nephrolithiasis Clinical Trials

Efficacy of Tranexamic Acid on Blood Loss During Percutaneous Nephrolithotomy.

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Efficacy of tranexamic acid on blood loss during percutaneous nephrolithotomy. a double-blind, placebo-controlled randomized clinical trial.

NCT ID: NCT04352153 Recruiting - Hyperuricemia Clinical Trials

Role of Uralyt-U in Patients With Hyperuricemia

Start date: April 1, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to provide a more direct and objective basis for the widespread use of potassium sodium hydrogen citrate granules in the treatment of uric acid stones.

NCT ID: NCT04346485 Recruiting - Urolithiasis Clinical Trials

Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers

Start date: March 13, 2020
Phase: N/A
Study type: Interventional

The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows: - decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.; - increasing the flexible ureteroscope tip deflection lower pole stones availability; - decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber; - increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter