General information Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Evaluation of the efficacy and safety of the potassium citrate tablet of immediate release vs Acalka® of prolonged release in the treatment of urolithiasis in adults. Phase IIIa / IIIb
Acronym of Scientific Title:
Secondary indentifying numbers:
Issuing authority of the secondary identifying numbers:
Oriente Pharmaceutical Laboratory Company
Source(s) of monetary or material support:
Oriente Pharmaceutical Laboratory Company
Authorization for beginning Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Reference number:
Tomo 06 Folio 00000005 No.073/05.015.20MB Date 2021/03/08
Principal investigator Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
Medical Specialty :
Doctor in Medical Sciences, Master in Medical Emergencies, Master in Diagnostic Means. 2nd grade Nephrology specialist. Auxiliary Professor and Auxiliary researcher
Affiliation:
Institute of Nephrology "Abelardo Buch Lopez"
Telephone:
+53-78813968
+53-78816442
Clinical sites to participate Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Recruitment status Section to complete information about the recruitment status and the date of first enrolment subject
Date of first enrollment:
Health condition and Intervention Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Health condition(s) code:
Urolithiasis
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Female Urogenital Diseases
Intervention(s):
Potassium Citrate group (experimental): Three tablets daily (30 mEq) orally, which must be swallowed whole, with plenty of fluids and divided into 3 frequencies (30 minutes after breakfast, lunch and dinner) for 3 months.
Acalka® group (Control): Three tablets daily (30 mEq) orally, which must be swallowed whole, with plenty of fluids and divided into 3 frequencies (30 minutes after breakfast, lunch and dinner) for 15 days.
Treatment of patients in both groups will be on an outpatient basis after a washout period of 12 days or more if they have been taking any urinary alkalinizer.
Intervention code:
Potassium Citrate
Tablets
Administration, Oral
Outcomes and Timepoint Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
1. Excretion of citrate in the urine (citraturia). Measurement time: At baseline, 15 days, and 3 months.
2. Variation in urinary pH. Measurement time: At baseline, 15 days, and 3 months.
Key secondary outcomes:
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.
Selection criterias Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
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 Section to complete information about the characteristics of the study design.
Allocation:
Randomized controlled trial
Target sample size:
Stage 1: 160 Stage 2: 160
Contact for public queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
Specialty:
Master in Clinical Trials. Industrial Engineer
Affiliation:
National Coordinating Center for Clinical Trials (CENCEC)
Postal Address:
5ta A e/ 60 y 62, Miramar, Playa
Contact for scientific queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
Specialty:
Doctor in Medical Sciences, Master in Medical Emergencies, Master in Diagnostic Means. 2nd grade Nephrology specialist. Auxiliary Professor and Auxiliary Researcher
Affiliation:
Institute of Nephrology "Abelardo Buch Lopez"
Data Sharing Section to complete the data related to the data sharing plan.
Research Ethics Committees Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
Institute of Nephrology "Abelardo Buch Lopez"
Status of evaluation date of Ethic Committee:
Postal address of Ethic Committee :
Ave. 26 and Boyeros, Havana, ZC: 24100, Cuba
About study completion Section to complete the data related to the study completion.
Date of available results:
Date of first publication:
Registration and Update Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
