Evaluation of the efficacy and safety of the potassium citrate tablet of immediate release vs Acalka® in urolithiasis in adults.

Phase 3

• Conditions: Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Renal urolithiasis; Nephrolithiasis; Kidney Diseases; Male Urogenital Diseases

• Registration Number: RPCEC00000333
• Lead Sponsor: Oriente Pharmaceutical Laboratory Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-09
• Study Completion: 2023-06-15
• Results First Posted: 2023-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1- Adults (19-75 years, both inclusive).
2- Patients who have given their informed consent to participate in the study.
3- Patients who present in the urine metabolic study any of the metabolic alterations of hypercalciuria, hyperuricosuria, hyperoxaluria, hypocitraturia or cystinuria.
4- Patients who comply with the washout period (do not take any urinary alkalinizing medication) of 10 days or more, before recruitment.

Exclusion Criteria

1- Patients with struvite stones.
2- Patients with urinary infection.
3- Patients with a history of hyperkalemia or at risk of it (glomerular filtration rate less than 25 ml / min x 1.73 m2SC).
4- Patients with metabolic alkalosis (HCO3- in plasma greater than 33mEq / l).
5- Patients with a history of gastritis or active peptic ulcer, with delayed gastric emptying, with esophageal compression, obstruction or intestinal stricture.
6- Patients who are taking anticholinergic medications.
7- Patients who present any mental or physical condition that prevents them from collecting 24-hour urine.
8- Pregnant and postpartum patients who are breastfeeding.
9- Diabetic patients decompensated from the disease.
10- Patients who are taking potassium-sparing diuretics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Excretion of citrate in the urine (citraturia). Measurement time: At baseline, 15 days, and 3 months.<br>2. Variation in urinary pH. Measurement time: At baseline, 15 days, and 3 months.

Secondary Outcome Measures

Name	Time	Method
Adverse Events-AE (Occurrence of any AE (Yes or No), Description of AE (Name of the AE, according to the clinical manifestation that occurs), Severity of the adverse event (Serious / non-Serious), AE intensity (Mild, Moderate, Severe), Duration of the AE (Start and End dates of the adverse event), Causal relationship (Very probable / certain, probable, possible, unlikely, unrelated, not evaluable / not classifiable), Attitude towards treatment (No changes, temporary or definitive interruption of the treatment under study), AE result (Recovered, improved, persists, sequelae, death due to AE, or unknown), Lot (Lot code of the drug causing the AE)). Measurement time: 3 months.<br><br><br><br>