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Genetic Study of Nephrolithiasis in Gouty Diathesis
This study has been terminated.
(Non significative preliminary data)
Sponsor:
Mario Negri Institute for Pharmacological Research
Information provided by:
Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier:
NCT00149305
First received: September 7, 2005
Last updated: April 8, 2015
Last verified: October 2009
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Purpose
Gouty diathesis describes uric acid or calcium oxalate nephrolithiasis and low urinary pH (<5.5). A hereditary component has been outlined for several forms of nephrolithiasis (such as hypercalciuria, hyperoxaluria, cystinuria, renal tubular acidosis), leading to the hypothesis of a genetic predisposition to nephrolithiasis. At the Unit of Nephrology, Ospedali Riuniti di Bergamo, more than 100 patients affected by gouty diathesis are followed. Fifty percent of them has a familiarity for kidney stones formation. The aim of our study is to identify the genetic factors that predispose to the development of nephrolithiasis in patients with gouty diathesis.
| Condition | Intervention |
|---|---|
| Nephrolithiasis | Other: Genetic analyses |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Genetic Study of Nephrolithiasis in Gouty Diathesis |
Resource links provided by NLM:
Further study details as provided by Mario Negri Institute for Pharmacological Research:
Biospecimen Retention: Samples With DNA
Show Detailed Description
Whole blood on EDTA
| Enrollment: | 37 |
| Study Start Date: | May 2005 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Patients with gouthy diathesis | Other: Genetic analyses |
| Healthy subjects | Other: Genetic analyses |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 10 Years to 85 Years (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Unrelated patients with familial form of nephrolithiasis associated with gouty diathesis (at least two affected subjects within a family).
Criteria
Inclusion Criteria:
- male and female, ≥ 10 years of age
- uric acid or calcium oxalate nephrolithiasis
- urinary 24 h pH < 5.5 in absence of high animal protein intake (urinary sulphate excretion <25 mM/24 h after one week of low animal protein intake)
- familial history of kidney stones (at least two first or second degree family members affected)
- written informed consent according to the Declaration of Helsinki guidelines
Exclusion Criteria:
- renal colic in the 4 weeks preceding evaluations
- excessive gastrointestinal alkali loses
- inability to fully understand the purposes of the study or to provide a written informed consent
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00149305
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149305
Locations
| Italy | |
| Clinical Research Center for Rare Diseases | |
| Ranica, Bergamo, Italy, 24020 | |
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
| Principal Investigator: | Erica Daina, MD | Mario Negri Institute |
More Information
| Responsible Party: | Mario Negri Institute for Pharmacological Research |
| ClinicalTrials.gov Identifier: | NCT00149305 History of Changes |
| Other Study ID Numbers: |
GOUTY DIATESIS |
| Study First Received: | September 7, 2005 |
| Last Updated: | April 8, 2015 |
Keywords provided by Mario Negri Institute for Pharmacological Research:
|
Gouty diathesis Acid uric nephrolithiasis |
Additional relevant MeSH terms:
|
Nephrolithiasis Kidney Calculi Disease Susceptibility Kidney Diseases Urologic Diseases Urolithiasis |
Urinary Calculi Calculi Pathological Conditions, Anatomical Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on July 25, 2017