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

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.

Acronym of Public Title:

ESCPTUA

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:

EESCPTAUA

Secondary indentifying numbers:

ECCP00

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)

Authorization date :

16/02/2021

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.

First name:

Raymed

Midle name:

Antonio

Last name:

Bacallao Mendez

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"

Postal address:

Ave. 26 esq. Boyeros

City:

Havana

País:

Cuba

Zip Code:

24100

Telephone:

+53-78813968

+53-78816442

Email address:

raymed@infomed.sld.cu

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:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

20/05/2021

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:

Renal urolithiasis

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

Intervention keyword:

Acalka

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.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

75 years

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

3

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

First Name:

Pedro

Middle Name:

Pablo

Last Name:

Guerra Chaviano

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

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164124

Email :

pedropa@infomed.sld.cu

pedrop@cencec.sld.cu

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.

First Name:

Raymed

Middle Name:

Antonio

Last Name:

Bacallao Mendez

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"

Postal Address:

Ave. 26 esq. Boyeros

City:

Havana

País:

Cuba

Zip Code:

24100

Telephone:

+53-78813968

Email :

raymed@infomed.sld.cu

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:

In review

Status of evaluation date of Ethic Committee:

17/08/2020

Postal address of Ethic Committee :

Ave. 26 and Boyeros, Havana, ZC: 24100, Cuba

Telephone:

+53-78816442

Correo electrónico:

raymed@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

150

Study completion date:

17/11/2022

Date of available results:

15/06/2023

Date of first publication:

30/11/2023

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).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000333

Date of Registration in Primary Registry:

09/09/2020

Record Verification Date:

2023/03/31

Next update date:

2024/03/31

Link to the spanish version:

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

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