Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
Summary
The purpose of this study is to determine whether Renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters will be assessed every 4 weeks.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Recurrent Calcic Urolithiasis
Intervention
Renalof, Placebo
Location
Institute of Nephrology
Havana City
Havana
Cuba
10400
Status
Completed
Source
Catalysis SL
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01022060
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Urolithiasis
Formation of stones in any part of the URINARY TRACT, usually in the KIDNEY; URINARY BLADDER; or the URETER.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Prolidase Deficiency
Rare autosomal recessive disorder of metabolism due to mutations in the prolidase gene. It is characterized by recurrent lower extremity skin ulcers, recurrent infections, and FACIES, often with mental retardation.
Irritable Bowel Syndrome
A disorder with chronic or recurrent colonic symptoms without a clearcut etiology. This condition is characterized by chronic or recurrent ABDOMINAL PAIN, bloating, MUCUS in FECES, and an erratic disturbance of DEFECATION.
Clinical Trials
Renalof in the Treatment of Elderly Patients With Gallstones
The purpose of this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evalu...
SLC26 Anion Transporter Gene Variants to Idiopathic Calcium Oxalate Urolithiasis
The goal of the study is to pilot test the collection of blood samples for DNA isolation from 100 patients presenting with idiopathic calcium urolithiasis (cases) and 100 patients with neg...
Tamsulosin for Urolithiasis in the Emergency Dept
Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In the US there are over 1.1 million visits annually to Emergency Departments for renal colic. Th...
Does Treatment With Alfuzosin Increase Success Rates of (SWL) Shock Wave Lithotripsy
In latest literature more evidence is available about the positive effect of alpha blocker on stone expulsion from the ureter. Patients benefit from less pain and shortening time to stone...
Use of G-CSF for the Treatment of Unexplained Recurrent Miscarriage
In order to investigate the effectiveness of G-CSF in preventing embryo demise, the investigators administered this cytokine to women with recurrent miscarriage in a randomized controlled...
PubMed Articles
Primary hyperparathyroidism (PHPT) is a disease to cause calcium, phosphorus, bone metabolism abnormality by the over secretion of parathyroid hormone (PTH) . A rise of PTH brings hypercalcemia, hypop...
Urolithiasis and calcium metabolism. Epidemiology of urolithiasis.
Recently, urolithiasis is increasing in the world. The onset of urolithiasis is considered to associate with high protein and fat dietary habits. In the articles, using epidemiological method and rese...
Urolithiasis and calcium metabolism. The vital relationship between Osteopontin and Urolothiasis.
Urological rediscovery of osteopontin (OPN) in 1992 has opened a new era in the understanding of mechanisms in development of urolithiasis over the two decades. OPN had the multiple functions, and it...
Urolithiasis and calcium metabolism. Surgical Management for Urolithiasis.
The indication of the surgical management for urolithiasis isn't decided only in the size of the stone. Even the small stone sometimes influences a kidney function and clinical symptom. Present Japane...
The components of metabolic syndrome, such as obesity, hypertension, and diabetes, are thought to be associated with urolithiasis. However, there are few large-scale studies that have examined the ass...
