A Phase 4 interventional study of MANOSAR® and Proanthocyanidins in Kidney Transplant Infection, sponsored by Arafarma Group, S.A.. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by Arafarma Group, S.A. · Phase 4, Interventional, and Prevention
The incidence of Urinary tract infections (UTIs) is very high in kidney transplant patients. Most UTIs occur during the first six months (82% within the first three months) of kidney transplantation and are frequently recurrent. The component D-mannose of our authorized food supplement acts by inhibiting the adherence of E.coli to the urothelium. It also has a controlled release formula that ensures the presence in urine of D-mannose and the other components during 24 hours. This is the reason why this experimental study aims to demonstrate that the oral intake of this food supplement is effective in the prevention of UTIs in kidney transplant patients.
The study tries to analyze the impact of a food supplement (Manosar®) on the incidence of urinary infections in patients undergoing kidney transplantation.
The patients will be randomly distributed (1: 1 ratio) into two treatment groups of 30 patients each. In one group, they will be treated with Manosar®, and in the other group they will be treated with Proanthocyanidins. All patients will be followed for 6 months, being the first three months of the study drug administration.
This experimental study is double-blinded and there are 7 monthly study visits. Properties of D-mannose and Proanthocyanidins make interesting to evaluate the clinical benefit of the use of food supplements with D-mannose and Proanthocyanidins in order to prevent the UTIs without antibiotics.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 60 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Arafarma Group, S.A. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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MANOSAR® is an authorized food supplement that contains D-mannose, Proanthocyanidins, Ursolic Acis, vitamin complexes and ions, and protects against urinary tract infections.
Dietary Supplement: MANOSAR®
The comparator are Proanthocyanidins of continuous-release, which are isolated from cranberry, and prevents the adhesion of uropathogenic bacteria such a E.coli to the wall of the urothelium.
Dietary Supplement: Proanthocyanidins
MANOSAR® is an authorized food supplement that contains D-mannose, Proanthocyanidins, Ursolic Acis, vitamin complexes and ions, and protects against urinary tract infections.
Also known as: Food Supplement
The comparator are Proanthocyanidins of continuous-release, which are isolated from cranberry, and prevents the adhesion of uropathogenic bacteria such a E.coli to the wall of the urothelium.
Change on the incidence of urinary tract infections.
To assess the magnitude of the change from baseline incidence of urinary tract infections in kidney transplant patients at one month, two months and three months of treatment and at four, five and six months of follow-up.
Time frame: Baseline to 1, 2, 3, 4, 5 and 6 months
Rate of three types of urinary tract infection: asymptomatic bacteriuria, cystitis, and pyelonephritis between both treatment groups.
All information regarding these infections will be recorded.
Time frame: Baseline to all study visits up to 6 months.
Rate of urinary tract infections caused by E.coli.
E. coli will be assessed by urine cultures, which are performed according to the usual clinical practice of the site (weekly - from Visit 0 to Visit 1 (4 urine cultures); fortnightly - from Visit 1 to Visit 3 (4 urine cultures); monthly - from Visit 3 to Visit 6 (3 urine cultures)). Also if there is suspected infection based on clinical criteria there will be performed also an urine culture.
Time frame: Baseline to all study visits up to 6 months.
Rate of patients who developed bacteremia during the episode of pyelonephritis.
This will be assessed in relation to the performance of urine cultures.
Time frame: Baseline to all study visits up to 6 months.
Rate of safety episodes between both treatment groups.
All episodes will be recorded, whether considered minor or serious, drug-related or not.
Time frame: From Visit 1, and at each visit, up to 6 months.
Rate of incidence of delayed renal graft function.
This is assessed by the need for a hemodialysis session.
Time frame: From Visit 0 to Visit 1, up to 1 month.
Change from baseline in both treatment groups of concentration of glucose in renal function.
The concentration of glucose (mmol/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Time frame: Baseline to all study visits up to 6 months.
Rate of histologically confirmed acute rejection and number of patients who lost the kidney graft.
Assessed during the 6 months study.
Time frame: Baseline to all study visits up to 6 months.
Rate of bacterial colonization of the double J catheter in both treatment groups.
This is assessed by the microbiological analysis of the tips of the double J catheter will be performed between Visit 0 and Visit 1, once it has been removed 21-27 days after kidney transplantation.
Time frame: From Visit 0 to Visit 1, up to 1 month.
Type of bacterial colonies of the double J catheter
This is assessed by the microbiological analysis of the tips of the double J catheter will be performed between Visit 0 and Visit 1, once it has been removed 21-27 days after kidney transplantation.
Time frame: From Visit 0 to Visit 1, up to 1 month.
Change from baseline in both treatment groups of concentration of Glomerular Filtration Rate (GFR).
The calculation of GFR (ml/min) is estimated with a blood test, which is completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Time frame: Baseline to all study visits up to 6 months.
Change from baseline in both treatment groups of concentration of serum creatinine in renal function.
The concentration of serum creatinine (µmol/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Time frame: Baseline to all study visits up to 6 months.
Change from baseline in both treatment groups of concentration of sodium in renal function.
The concentration of sodium (mEq/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Time frame: Baseline to all study visits up to 6 months.
Change from baseline in both treatment groups of concentration of potassium in renal function.
The concentration of potassium (mEq/L) is assessed by the value results of the laboratory analysis, which are completed according to the usual clinical practice of the site for the follow-up of kidney transplant patients: weekly - from Visit 0 to Visit 1 (4 tests); fortnightly - from Visit 1 to Visit 3 (4 tests); monthly - from Visit 3 to Visit 6 (3 tests).
Time frame: Baseline to all study visits up to 6 months.
Plan to share: Undecided
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Arafarma Group, S.A.