Kidney Transplant InfectionPhase 4MANOTRASNCT05109455
Effects of a Food Supplement in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.
A Phase 4 study testing MANOSAR® and Proanthocyanidins in people with Kidney Transplant Infection, run by Arafarma Group, S.A. at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Infection
- What is being tested?
- MANOSAR® and Proanthocyanidins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 16 Apr 2019to 17 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years.
- Recipients of a cadaveric donor kidney transplant.
- Patients who are trained to give their informed consent.
Who cannot join
- Recipients of a kidney transplant who do not authorize their participation in the study by informed consent.
- Recipients of a transplant of an organ other than the kidney.
- Patients with Bricker or Studer neobladders.
- Patients in need of intermittent self-catheterization prior to kidney transplantation.
- Any medical, psychiatric or family condition that, in the opinion of the investigator, may endanger or compromise the patient's ability to participate in the study.
- Pregnant or lactating patients.
- Having participated in clinical trials in the previous 3 months or participating in another clinical study promoted by the pharmaceutical industry, in which the promoter already establishes the treatment for UTI.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona
About this study
Official title: Study of a Food Supplement (Mannose and Proanthocyanidins Prolonged Release 24h) Versus Proanthocyanidins in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.
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.
Read the detailed description
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.
- Conditions
- Kidney Transplant Infection
- Being tested
- MANOSAR®, Proanthocyanidins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MANOSAR®Dietary supplement
Also called Food Supplement
MANOSAR® is an authorized food supplement that contains D-mannose, Proanthocyanidins, Ursolic Acis, vitamin complexes and ions, and protects against urinary tract infections.
ProanthocyanidinsDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Food supplement | Experimental | MANOSAR® is an authorized food supplement that contains D-mannose, Proanthocyanidins, Ursolic Acis, vitamin complexes and ions, and protects against urinary tract infections. Receives: Dietary Supplement: MANOSAR® |
| Comparator | Active comparator | 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. Receives: Dietary Supplement: Proanthocyanidins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 1, 2, 3, 4, 5 and 6 months
Secondary outcomes (13)
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.
Measured: Baseline to all study visits up to 6 months.
Rate of urinary tract infections caused by E.coli.
- 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline to all study visits up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start16 Apr 2019
- Primary completion25 Mar 2021
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arafarma Group, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edoardo Melilli, Doctor, Principal investigator, Unidad de Trasplante Renal - Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109455
- Sponsor's protocol ID
- ARA-EXP/MN-0801
- Acronym
- MANOTRAS
- Status last verified
- Mar 2023
- First submitted
- 21 Oct 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Food Supplement (Mannose and Proanthocyanidins Prolonged Release 24h) Versus Proanthocyanidins in the Prevention of Urinary Tract Infections in Kidney Transplant Patients.
- ClinicalTrials.gov ID
- NCT05109455
- Acronym / sponsor ID
- MANOTRAS / ARA-EXP/MN-0801
- Conditions
- Kidney Transplant Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Arafarma Group, S.A.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food supplement | Experimental | Dietary Supplement: MANOSAR®MANOSAR® is an authorized food supplement that contains D-mannose, Proanthocyanidins, Ursolic Acis, vitamin complexes and ions, and protects against urinary tract infections. |
| Comparator | Active comparator | Dietary Supplement: ProanthocyanidinsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years.
- Recipients of a cadaveric donor kidney transplant.
- Patients who are trained to give their informed consent.
Key exclusion criteria (7 listed)
- Recipients of a kidney transplant who do not authorize their participation in the study by informed consent.
- Recipients of a transplant of an organ other than the kidney.
- Patients with Bricker or Studer neobladders.
- Patients in need of intermittent self-catheterization prior to kidney transplantation.
- Any medical, psychiatric or family condition that, in the opinion of the investigator, may endanger or compromise the patient's ability to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MANOSAR®Also: Food SupplementMANOSAR® is an authorized food supplement that contains D-mannose, Proanthocyanidins, Ursolic Acis, vitamin complexes and ions, and protects against urinary tract infections. | Dietary supplement | Food supplement |
| ProanthocyanidinsThe 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 | Comparator |
Primary outcome
Change on the incidence of urinary tract infections.
Time frame: Baseline to 1, 2, 3, 4, 5 and 6 months
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.
13 secondary outcomes
Rate of three types of urinary tract infection: asymptomatic bacteriuria, cystitis, and pyelonephritis between both treatment groups.
Time frame: Baseline to all study visits up to 6 months.
Rate of urinary tract infections caused by E.coli.
Time frame: Baseline to all study visits up to 6 months.
Rate of patients who developed bacteremia during the episode of pyelonephritis.
Time frame: Baseline to all study visits up to 6 months.
Rate of safety episodes between both treatment groups.
Time frame: From Visit 1, and at each visit, up to 6 months.
Rate of incidence of delayed renal graft function.
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.
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.
Time frame: Baseline to all study visits up to 6 months.
Rate of bacterial colonization of the double J catheter in both treatment groups.
Time frame: From Visit 0 to Visit 1, up to 1 month.
Type of bacterial colonies of the double J catheter
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).
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.
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.
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.
Time frame: Baseline to all study visits up to 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edoardo Melilli, Doctor principal investigator
Unidad de Trasplante Renal - Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MANOSAR® and Proanthocyanidins in people with Kidney Transplant Infection, run by Arafarma Group, S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the incidence of urinary tract infections. (time frame: Baseline to 1, 2, 3, 4, 5 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.