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

NCT04695951 | Completed Phase 2

• 1 other identifier: 201920-RENALOF-NI
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Injury; Kidney Injury; Kidney Calculi; Ureteral Obstruction; Ureteral Calculi; Renal Stone; Ureteral Injury; Renal Disease; Urolithiasis, Calcium Oxalate; Urolithiasis; Lower Urinary Tract; Urolithiasis

Keywords

Urolithiasis; Kidney Stone; Agropyron Repens; Ureteral calculi; Calcium oxalate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of life of patients

  4 months

• Number of colic

  4 months

• Adverse events related with product of the trial

  4 months

Other Outcomes (1)

• Cost of treatment

  4 months

Study Arms (2)

Renalof

EXPERIMENTAL

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.

Dietary Supplement: Renalof

Control

PLACEBO COMPARATOR

A total of 35 patients treated with the study product 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.

Other: Placebo

Interventions

Renalof DIETARY_SUPPLEMENT

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.

Renalof

Placebo OTHER

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.

Control

Eligibility Criteria

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

You may qualify if:

• Patient over 18 years of age, in all their mental and physical capacities to decide to be part of this study.
• There are no comorbidities or associated diseases that put the stability of the patient at risk.
• Not be diagnosed as Chronic Kidney Disease, in any stage.
• Existence of non-obstructive stones smaller than 10 mm located in the renoureteral path.
• No compromise of renal viability.

You may not qualify if:

• Patients under 18 years of age.
• Existence of comorbidities or associated diseases that put the stability of the patient at risk.
• Existence of a diagnosis of Chronic Kidney Disease, at any stage.
• Presence of non-obstructive or obstructive stones greater than 10 mm located in the renoureteral path.
• Renal viability compromise.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (1)

Clinica Seniors Managua

Managua, 13035, Nicaragua

Location

Related Publications (11)

• 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.

  PMID: 18269444 BACKGROUND

• 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. doi: 10.1038/ki.1979.173.

  PMID: 548606 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.aje.a008769.

  PMID: 8610664 BACKGROUND

• 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. doi: 10.1097/01.asn.0000040593.93815.9d.

  PMID: 12506146 BACKGROUND

• 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.

  PMID: 23124115 BACKGROUND

• 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.

  PMID: 32905259 BACKGROUND

• Grases F, Ramis M, Costa-Bauza 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. doi: 10.1016/0378-8741(94)01218-o.

  PMID: 7623486 BACKGROUND

• 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.

  PMID: 28040531 BACKGROUND

• 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. doi: 10.1055/s-0028-1097720. No abstract available.

  PMID: 1005521 BACKGROUND

• 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.

  PMID: 22901953 BACKGROUND

• Hagerstrom E, Lindberg L, Bentzen J, Brodbaek 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.

  PMID: 30670924 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Ureteral Obstruction; Ureteral Calculi; Nephrolithiasis; Kidney Diseases; Nephrolithiasis, Calcium Oxalate; Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureteral Diseases; Ureterolithiasis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: January 6, 2021
• Study Start: August 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 6, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

NI (1)