Clinical trial NCT03836144: Effect of Urine Alkalinazation on Urinary Inflammatory Markers in Patients With Cystinuria
Official title: Effect of Urine Alkalinazation on Urinary Inflammatory Markers Analyzed Using Mass Spectrometry in Patients With Cystinuria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystinuria
Renal Lithiasis
Glomerulonephritis
Interstitial Nephritis
Keywords: Mass spectrometry
Cystinuria
Inflammation
Nephrolithiasis
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Sponsor Name Pending
First posted: 2019-02-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cystinuria, as well as patients with renal lithiasis not due to cystinuria and patients with an inflammatory renal pathology will be selected by the investigators of the study during their usual medical consultation.

At that time, patients will be given the information note and will be asked to sign the written informed consent.

Brief summary: It has recently been described the presence of a urinary inflammatory signature in patients with cystinuria, the most common cause of renal lithiasis of genetical origin. These data are very innovative in this pathology but deserve further studies to establish the specificity of this inflammatory signature in patients with cystinuria compared to other nephropathies and other renal lithiasis diseases. Moreover, the effect of the usual treatment of cystinuria (namely urine alkalanization) on urinary inflammatory biomarkers deserves to be tested.

The objectives of the present study are: i) To study the urinary inflammatory profile by mass spectrometry (a very efficient tool to detect and identify proteins) in patients with cystinuria and in patients with lithiasis of other origin and in patients with inflammatory renal disease ; ii) To study the potential effect of urine alkalinazation with potassium citrate (usual treatment according to European recommendations) on the inflammatory signature of patients with cystinuria. To this aim, urine of non treated cystinuric patients will be collected before treatement initiation and 3 months after the start of the alkalizing treatment.


Eligibility criteria: Inclusion Criteria:

* age superior or equal to 18 years
* patient able to understand the information note and to sign the informed consent
* patient with an Health coverage
* no current urinary tract infection (assessed by a cytobacteriological examination of the urine)
* For the cystinuria group: patient with cystinuria not yet treated or for whom the alkalizing treatment or the cystein binding thiol agents have been discontinuated for at least 3 months AND with an estimated GFR (using the MDRD formula) greater than 60 ml/min/1.73m2.
* For the control groups: patient presenting either a renal lithiasis not due to cystinuria, or an inflammatory renal pathology confirmed by an anterior renal biopsy (glomerulonephritis or interstitial nephritis) AND with an estimated GFR (using the MDRD formula) greater than 30 ml/ min/1.73m2.

Exclusion Criteria:

* Cystinuric patient already treated (whatever the treatment)

Primary outcomes:
measure: Change from baseline urine inflammatory profile after 3 months of alkalizing treatment using mass spectrometry in patients with cystinuria.
timeFrame: at inclusion and after three months of the usual alkalizing treatment for the patients with cystinuria
Secondary outcomes:
measure: Assessment of urine inflammatory profile in controls groups using mass spectrometry.
timeFrame: at inclusion for patients with a nephrolithiasis not due to cystinuria and in patients an inflammatory nephropathy of glomerular or tubulo interstitial origin
measure: Study of crystalluria (presence of crystals in urine) to assess nephrolithiasis activity.
timeFrame: at inclusion for these two groups and after three months of the usual alkalizing treatment for the patients with cystinuria
Other outcomes:
measure: Presence of stones in the renal cavities or in the urinary tract using ultrasonograhy.
timeFrame: at inclusion for these two groups and after three months of the usual alkalizing treatment for the patients with cystinuria
measure: Blood CRP concentrations to assess systemic inflammation
timeFrame: at inclusion for all groups and and after three months of the usual alkalizing treatment for the patients with cystinuria
Locations:
city: Paris
country: France
facility: Eurpean Georges Pompidou Hospital
state: Ile-de-France
Study officials:
References:
citation: Bourderioux M, Nguyen-Khoa T, Chhuon C, Jeanson L, Tondelier D, Walczak M, Ollero M, Bekri S, Knebelmann B, Escudier E, Escudier B, Edelman A, Guerrera IC. A new workflow for proteomic analysis of urinary exosomes and assessment in cystinuria patients. J Proteome Res. 2015 Jan 2;14(1):567-77. doi: 10.1021/pr501003q. Epub 2014 Nov 12.
citation: Prot-Bertoye C, Lebbah S, Daudon M, Tostivint I, Bataille P, Bridoux F, Brignon P, Choquenet C, Cochat P, Combe C, Conort P, Decramer S, Dore B, Dussol B, Essig M, Gaunez N, Joly D, Le Toquin-Bernard S, Mejean A, Meria P, Morin D, N'Guyen HV, Noel C, Normand M, Pietak M, Ronco P, Saussine C, Tsimaratos M, Friedlander G, Traxer O, Knebelmann B, Courbebaisse M; French Cystinuria Group. CKD and Its Risk Factors among Patients with Cystinuria. Clin J Am Soc Nephrol. 2015 May 7;10(5):842-51. doi: 10.2215/CJN.06680714. Epub 2015 Feb 25.