Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi

NCT04021381 | Unknown Phase 3

• 2 other identifiers: P170933J2018-A03500-55
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

The prevalence of urolithiasis is around 10 % in the French population. It is thus a major public health issue. When the stone is not spontaneously removed, interventions such as extracorporeal lithotripsy or flexible ureteroscopy (F-URS) are performed. F-URS is usually preferred in renal stones \> 7 mm in comparison with lithotripsy, with better results. Efficacy of ureteroscopy is based on the "stone-free rate" (SFR) at 3 months. A SFR index is assessed according to the existence of residual fragments and their size. SFR score 1 (fragment ≤ 1mm) has been poorly studied, and is supposed to occur in 60% of cases. These residual fragments account for the high frequency of recurrence, probably favored by crystals aggregation and growth of these fragments under supersaturated urines. Indeed, calcium stones risk factors are urine supersaturation and crystal growth inhibitors deficiency. Citrate is the major crystal growth inhibitor in human urine. A hypocitraturia is reported in half of the lithiasic population. Consequently, citrate salts appear as an interesting therapeutic option, in order to slow crystal growth but also to chelate calcium, and consequently to solubilize stones in situ. However, to date, there is no available controlled study after surgical intervention such as flexible ureteroscopy. The aim of the investigator's study is to evaluate the efficacy of a 3-month potassium and magnesium citrate treatment following ureteroscopy on the elimination of residual fragments (SFR score 1).

Conditions

Urolithiasis; Calyx; Calculus

Keywords

Urolithiasis; Urinary Calculi; Ureteroscopy; Residual fragments; Morphoconstitutional analysis; Citrate

Outcome Measures

Primary Outcomes (1)

• Stone-free result

  Percentage of stone-free patients (SFR score 0 and 1) between the 2 groups at 3 months after ureteroscopy assessed by non-injected, low irradiation, thin slice CT-scan.

  3 months

Secondary Outcomes (5)

• SFR score 2, 3 and 4

  3 months

• Urine supersaturation index

  3 months

• To evaluate the Safety of potassium and magnesium citrate: Percentage of patients with at least one adverse event throughout the study

  3 months

• To evaluate the compliance of potassium and magnesium citrate as assessed by citraturia

  3 months

• To evaluate the compliance of potassium and magnesium citrate as assessed by urinary pH

  3 months

Study Arms (2)

Potassium and magnesium citrate

EXPERIMENTAL

Patients are treated with potassium and magnesium citrate

Dietary Supplement: Potassium and magnesium citrate

Placebo

PLACEBO COMPARATOR

Patients are treated with placebo

Dietary Supplement: Placebo

Interventions

Potassium and magnesium citrate DIETARY_SUPPLEMENT

Patients are treated with potassium and magnesium citrate 5.2 grams daily during 3 months, following flexible ureterorenoscopy for inferior calyx urolithiasis.

Also known as: Lithos

Potassium and magnesium citrate

Placebo DIETARY_SUPPLEMENT

Patient are treated with placebo 5.2 grams daily during 3 months, following flexible ureterorenoscopy for inferior calyx urolithiasis.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Efficient contraceptive method in women of childbearing age
• At least one renal urolithiasis 10 ≤ size ≤ 20 mm
• No recent ureterorenoscopy (\< 6 months)
• Planned flexible ureterorenoscopy procedure with holmium-laser dusting
• CT-scan performed within 3 months before surgery
• Affiliation to a social security regime
• Informed consent

You may not qualify if:

• Stone density \< 700 UH on pre-operative CT-scan
• History of infectious renal stones or monogenic lithiasic disease (cystinuria, primary hyperoxaluria)
• Obstructive urinary tract malformation Cacchi-Ricci disease, Horseshoe kidney
• Chronic renal failure (eGFR\<30 ml/min/1.73m²)
• Ongoing renal colic (within 7 days)
• Untreated urinary tract infection (within 7 days)
• Contraindications to ureterorenoscopy: coagulation disorders, high anesthetic risk
• Contraindications to potassium and magnesium citrate: known hyperkalemia, known hypermagnesemia, uncontrolled diabetes, acute dehydration
• Pregnant or breastfeeding women
• Patient deprived of liberty or under legal protection measure (tutorship or curatorship);
• Participation in another therapeutic trial

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department : Exploration fonctionnelles rénales, Centre de la lithiase Hôpital TENON

Paris, 75020, France

RECRUITING

MeSH Terms

Conditions

Urolithiasis; Calculi; Urinary Calculi

Interventions

potassium-magnesium citrate

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathalie TABIBZADEH, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie TABIBZADEH, MD

CONTACT

+ 33 1 56 01 83 29; nathalie.tabibzadeh@aphp.fr

Jean-Philippe HAYMANN

CONTACT

+33 1 56 01 67 74; jean-philippe.haymann@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: July 16, 2019
• Study Start: September 25, 2020
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)