Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract

Urolithiasis Clinical Trial

Official title:

Efficacy and Safety of Renalof® in the Removal of Calculi Smaller Than 10 mm Located in the Reno-Ureteral Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04695951
• Other study ID #: 201920-RENALOF-NI
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2020
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Given the high recurrence of urolithiasis in patients, the search for less aggressive and preventive treatments is increasingly necessary. Renalof® is presented as an alternative to herbal medicine being a product that, due to its diuretic and demineralization properties of kidney stones, has been widely used in this patient population, disintegrating and eliminating calcium oxalate and struvite stones in a painless in the genitourinary system.

With the objective of determining the efficacy of this therapy, an observational, prospective, randomized, single-blind, two-arm study was carried out: treatment group with Renalof® and control group, placebo.

Description:

Given the high recurrence of urolithiasis in patients, the search for less aggressive and preventive treatments is increasingly necessary. Renalof® is presented as an alternative to herbal medicine being a product that, due to its diuretic and demineralization properties of kidney stones, has been widely used in this patient population, disintegrating and eliminating calcium oxalate and struvite stones in a painless in the genitourinary system.

With the objective of determining the efficacy of this therapy, an observational, prospective, randomized, single-blind, two-arm study was carried out: treatment group with Renalof® and control group, placebo.

The treatment group consists of 120 patients over 18 years of age, of both sexes, with a diagnosis of urolithiasis less than 10 mm in diameter, present throughout the entire reno-uretero-bladder path, diagnosed by ultrasound, renal CT and urography . The Renalof® product was administered at a dose of 650 mg daily for 3 months and the presence of stones in any location of the reno-ureteral tract was evaluated using one of the diagnostic means mentioned in monthly consultations. The second group, treated with placebo corresponding to 35 people constituting 30% of the universe. The study period was from August 2019 to July 2020 at the Hospital Escuela Antonio Lenin Fonseca and the Seniors clinic, in the city of Managua, Nicaragua.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: October 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient over 18 years of age, in all their mental and physical capacities to decide to be part of this study.

2. There are no comorbidities or associated diseases that put the stability of the patient at risk.

3. Not be diagnosed as Chronic Kidney Disease, in any stage.

4. Existence of non-obstructive stones smaller than 10 mm located in the renoureteral path.

5. No compromise of renal viability.

Exclusion Criteria:

1. Patients under 18 years of age.

2. Existence of comorbidities or associated diseases that put the stability of the patient at risk.

3. Existence of a diagnosis of Chronic Kidney Disease, at any stage.

4. Presence of non-obstructive or obstructive stones greater than 10 mm located in the renoureteral path.

5. Renal viability compromise.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Injury
• Nephrolithiasis
• Renal Disease
• Renal Injury
• Renal Stone
• Ureteral Calculi
• Ureteral Injury
• Ureteral Obstruction
• Ureterolithiasis
• Urolithiasis
• Urolithiasis, Calcium Oxalate
• Urolithiasis; Lower Urinary Tract
• Wounds and Injuries

Intervention

Dietary Supplement:
• Renalof
A total of 120 patients treated with the study product Renalof® at a dose of 650 mg twice daily were followed for 4 months. A preliminary analysis of the types of stones present in the study patients was performed according to the main compound, using a biophysical profile by biochemical analysis and the clinical characteristics, medical history and biochemical profile of the creatinine values of the test patients. Imaging and quality of life tests were carried out during the trial to check the efficacy and possible adverse effects of the test product in patients with kidney stones.

Other:
• Placebo
A total of 35 patients treated with Placebo at a dose of 650 mg twice daily were followed for 4 months. A preliminary analysis of the types of stones present in the study patients was performed according to the main compound, using a biophysical profile by biochemical analysis and the clinical characteristics, medical history and biochemical profile of the creatinine values of the test patients. Imaging and quality of life tests were carried out during the trial to check the efficacy and possible adverse effects of the test product in patients with kidney stones.

Locations

Country	Name	City	State
Nicaragua	Clinica Seniors Managua	Managua

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Nicaragua, 

References & Publications (11)

Beydokthi SS, Sendker J, Brandt S, Hensel A. Traditionally used medicinal plants against uncomplicated urinary tract infections: Hexadecyl coumaric acid ester from the rhizomes of Agropyron repens (L.) P. Beauv. with antiadhesive activity against uropathogenic E. coli. Fitoterapia. 2017 Mar;117:22-27. doi: 10.1016/j.fitote.2016.12.010. Epub 2016 Dec 29. — View Citation

Bragadottir G, Redfors B, Ricksten SE. Mannitol increases renal blood flow and maintains filtration fraction and oxygenation in postoperative acute kidney injury: a prospective interventional study. Crit Care. 2012 Aug 17;16(4):R159. doi: 10.1186/cc11480. — View Citation

Grases F, Ramis M, Costa-Bauzá A, March JG. Effect of Herniaria hirsuta and Agropyron repens on calcium oxalate urolithiasis risk in rats. J Ethnopharmacol. 1995 Mar;45(3):211-4. — View Citation

Hägerström E, Lindberg L, Bentzen J, Brødbæk K, Zerahn B, Kristensen B. The Nephroprotective Effect of Mannitol in Head and Neck Cancer Patients Receiving Cisplatin Therapy. Clin Med Insights Oncol. 2019 Jan 7;13:1179554918821320. doi: 10.1177/1179554918821320. eCollection 2019. — View Citation

Johnson CM, Wilson DM, O'Fallon WM, Malek RS, Kurland LT. Renal stone epidemiology: a 25-year study in Rochester, Minnesota. Kidney Int. 1979 Nov;16(5):624-31. — View Citation

Kohri K, Yasui T, Okada A, Hirose M, Hamamoto S, Fujii Y, Niimi K, Taguchi K. Biomolecular mechanism of urinary stone formation involving osteopontin. Urol Res. 2012 Dec;40(6):623-37. doi: 10.1007/s00240-012-0514-y. Epub 2012 Nov 6. Review. — View Citation

Mykoniatis I, Sarafidis P, Memmos D, Anastasiadis A, Dimitriadis G, Hatzichristou D. Are endourological procedures for nephrolithiasis treatment associated with renal injury? A review of potential mechanisms and novel diagnostic indexes. Clin Kidney J. 2020 May 22;13(4):531-541. doi: 10.1093/ckj/sfaa020. eCollection 2020 Aug. Review. — View Citation

Paslawska S, Piekos R. Studies on the optimum conditions of extraction of silicon species from plants with water. IV. Agropyron repens. Planta Med. 1976 Nov;30(3):216-22. — View Citation

Soucie JM, Coates RJ, McClellan W, Austin H, Thun M. Relation between geographic variability in kidney stones prevalence and risk factors for stones. Am J Epidemiol. 1996 Mar 1;143(5):487-95. — View Citation

Tsujihata M. Mechanism of calcium oxalate renal stone formation and renal tubular cell injury. Int J Urol. 2008 Feb;15(2):115-20. doi: 10.1111/j.1442-2042.2007.01953.x. Review. — View Citation

Wesson JA, Johnson RJ, Mazzali M, Beshensky AM, Stietz S, Giachelli C, Liaw L, Alpers CE, Couser WG, Kleinman JG, Hughes J. Osteopontin is a critical inhibitor of calcium oxalate crystal formation and retention in renal tubules. J Am Soc Nephrol. 2003 Jan;14(1):139-47. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of treatment	cost of treatment with the use of Renalof® compared to the usual treatments, taking into account hospitalization time due to the number of colic and recovery time due to urolithiasis	4 months
Primary	kidney stone clearance with Renalof® treatment compared to placebo	kidney stone clearance with Renalof® treatment compared to placebo measured by ultrasound and tomography imaging	4 months
Secondary	Quality of life of patients	Quality of life was established in relation to the presence or absence of symptoms related to the disease by means of a bimonthly personal questionnaire: dysuria or burning when urinating, urinary urgency, kidney colic, difficulty in performing daily activities and periodicity of urinary infections (mild, moderate, severe, yes or no,).	4 months
Secondary	Number of colic	number of colic during the 4-month follow-up of treatment	4 months
Secondary	Adverse events related with product of the trial	Adverse effects related with the test product in patients with kidney stones, measured by means of a bimonthly personal questionnaire: nausea, vomiting, digestive pain, stomach ache... (mild, moderate, severe, yes or no,).	4 months