Chronic Kidney FailureNCT01450657
Observational Study of Kibow Biotics in Chronic Kidney Failure Patients
An observational study of Chronic Kidney Failure, run by Kibow Pharma at 1 site in United States.
Trial summary
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- Kibow Biotics/Renadyl
- Type of treatment
- Pill or oral medicine
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2012
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient hospital setting.
Who may be able to join
- Age 18 to 75 years
- CKD Stages 3 and 4 as documented by prior medical history
- Serum Creatinine >2.5 mg/dL
- Stable and on CKD status 3 and 4 at least for a year or more
Who cannot join
- Pregnant or nursing women
- Refusal to sign the informed consent form
- Documented to have HIV/AIDS/Liver disease
- Active dependency on drugs or alcohol
- Any non-related medical, debilitating disease/disorder that would interfere with adherence to this study
- Currently on anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Observational Clinical Trials of Kibow Biotics (a Patented and Proprietary Probiotic Dietary Supplement) in Chronic Kidney Failure Patients, in Conjunction With Standardized Care of Treatment
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing standardized care of treatment for their CKD stage 3 and stage 4 conditions.
Read the detailed description
Probiotics are increasingly utilized clinically. As their safety and health benefits are established, it is reasonable to anticipate that probiotic bacteria will be incorporated into a growing number of clinical regimens, as a dietary supplement.
Extensive in vitro R\&D investigations in Kibow's laboratories
Bacterial strains studied were a mixture of patented and proprietary strains of Streptococcus thermophilus (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).
Oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat model (at Thomas Jefferson University, Phila., PA) and minipig model (at Indiana University, Indianapolis, IN), decreased both blood urea nitrogen (BUN) and serum creatinine (Scr) levels.
Two independent veterinarians investigated the effect of Kibow Biotics® in cats and dogs (of both genders and varying body weights) with moderate to severe kidney failure. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA.
Pilot scale studies, double blind, placebo controlled, cross-over studies for six months conducted in 45 patients in USA, Canada, Argentina, and Nigeria demonstrates reduction of BUN (P>95%) and improved quality of life (P>95%). Decrease in creatinine and uric acid levels were also observed. However, these studies were based on correlating the age of geriatric cats and dogs with moderate to significant kidney failure to human geriatric conditions. The proposed current study is being reevaluated based on correlating the weight basis of animal to human conditions. Hence, this is a does escalation study on ingestion of 1x (90 billion CFU/day), 2x (180 billion CFU/day), and 3x (270 billion CFU/day) dosages.
- Conditions
- Chronic Kidney Failure
- Being tested
- Kibow Biotics/Renadyl
- Keywords
- Chronic Kidney failure stage three and four, Probiotics, Kibow Biotics, Dialysis, Gut based uremic toxin removal
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kibow Biotics/RenadylDietary supplement
Also called Kibow Biotics
Month 1, one capsule three times daily (90 colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3 \& 4, three capsules three times daily (270 CFU's). Months 5 \& 6 are washout periods, in which the patient receives no product. All parameters are still monitored by the study site during months 5 \& 6. All medical, physical, clinical, QOL and other parameters will be monitored as well.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Failure 3/4 | Not described Receives: Dietary Supplement: Kibow Biotics/Renadyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
15-20% Changes in BUN.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months.
15-20% Change in Creatinine
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
Secondary outcomes (3)
Quality of life outcome based on questionnaire.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
To observe inflammatory and oxidative stress biomarkers.
Observe inflammatory and stress markers in metabolites from blood serum.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
Observation and analysis of patient fecal matter.
Observation and analysis of patient fecal matter to determine bacterial flora levels that are present in the stool.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kibow Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Responsible party
- Sponsor
- Investigators
- Stephanie DeLoach, M.D., Principal investigator, Thomas Jefferson University, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450657
- Sponsor's protocol ID
- KIB002
- Status last verified
- Aug 2017
- First submitted
- 26 Sep 2011
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ranganathan N, Friedman EA, Tam P, Rao V, Ranganathan P, Dheer R. Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada. Curr Med Res Opin. 2009 Aug;25(8):1919-30. doi: 10.1185/03007990903069249.
PubMed 19558344Ranganathan N, Ranganathan P, Friedman EA, Joseph A, Delano B, Goldfarb DS, Tam P, Rao AV, Anteyi E, Musso CG. Pilot study of probiotic dietary supplementation for promoting healthy kidney function in patients with chronic kidney disease. Adv Ther. 2010 Sep;27(9):634-47. doi: 10.1007/s12325-010-0059-9. Epub 2010 Aug 16.
PubMed 20721651
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Clinical Trials of Kibow Biotics (a Patented and Proprietary Probiotic Dietary Supplement) in Chronic Kidney Failure Patients, in Conjunction With Standardized Care of Treatment
- ClinicalTrials.gov ID
- NCT01450657
- Acronym / sponsor ID
- KIB002
- Conditions
- Chronic Kidney Failure
- Keywords
- Chronic Kidney failure stage three and four, Probiotics, Kibow Biotics, Dialysis, Gut based uremic toxin removal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kibow PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Oct 2011 (estimated)
- 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.
A specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing standardized care of treatment for their CKD stage 3 and stage 4 conditions.
Detailed description
Probiotics are increasingly utilized clinically. As their safety and health benefits are established, it is reasonable to anticipate that probiotic bacteria will be incorporated into a growing number of clinical regimens, as a dietary supplement.
Extensive in vitro R\&D investigations in Kibow's laboratories
Bacterial strains studied were a mixture of patented and proprietary strains of Streptococcus thermophilus (KB27), Lactobacillus acidophilus (KB31) and Bifidobacterium longum (KB35).
Oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat model (at Thomas Jefferson University, Phila., PA) and minipig model (at Indiana University, Indianapolis, IN), decreased both blood urea nitrogen (BUN) and serum creatinine (Scr) levels.
Two independent veterinarians investigated the effect of Kibow Biotics® in cats and dogs (of both genders and varying body weights) with moderate to severe kidney failure. Based on positive results, this formulation, marketed and distributed as AzodylTM, is currently licensed for veterinary applications to Vetoquinol USA.
Pilot scale studies, double blind, placebo controlled, cross-over studies for six months conducted in 45 patients in USA, Canada, Argentina, and Nigeria demonstrates reduction of BUN (P>95%) and improved quality of life (P>95%). Decrease in creatinine and uric acid levels were also observed. However, these studies were based on correlating the age of geriatric cats and dogs with moderate to significant kidney failure to human geriatric conditions. The proposed current study is being reevaluated based on correlating the weight basis of animal to human conditions. Hence, this is a does escalation study on ingestion of 1x (90 billion CFU/day), 2x (180 billion CFU/day), and 3x (270 billion CFU/day) dosages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Failure 3/4 | – | Dietary Supplement: Kibow Biotics/Renadyl |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient hospital setting.
Key inclusion criteria (4 listed)
- Age 18 to 75 years
- CKD Stages 3 and 4 as documented by prior medical history
- Serum Creatinine >2.5 mg/dL
- Stable and on CKD status 3 and 4 at least for a year or more
Key exclusion criteria (6 listed)
- Pregnant or nursing women
- Refusal to sign the informed consent form
- Documented to have HIV/AIDS/Liver disease
- Active dependency on drugs or alcohol
- Any non-related medical, debilitating disease/disorder that would interfere with adherence to this 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 |
|---|---|---|
| Kibow Biotics/RenadylAlso: Kibow BioticsMonth 1, one capsule three times daily (90 colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3 \& 4, three capsules three times daily (270 CFU's). Months 5 \& 6 are washout periods, in which the patient receives no product. All parameters are still monitored by the study site during months 5 \& 6. All medical, physical, clinical, QOL and other parameters will be monitored as well. | Dietary supplement | Chronic Kidney Failure 3/4 |
Primary outcome
15-20% Changes in BUN.
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months.
15-20% Change in Creatinine
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
3 secondary outcomes
Quality of life outcome based on questionnaire.
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
To observe inflammatory and oxidative stress biomarkers.
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months
Observation and analysis of patient fecal matter.
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 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 18 Aug 2017.
- Results publication: PubMed 19558344Ranganathan N, Friedman EA, Tam P, Rao V, Ranganathan P, Dheer R. Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada. Curr Med Res Opin. 2009 Aug;25(8):1919-30. doi: 10.1185/03007990903069249.
- Results publication: PubMed 20721651Ranganathan N, Ranganathan P, Friedman EA, Joseph A, Delano B, Goldfarb DS, Tam P, Rao AV, Anteyi E, Musso CG. Pilot study of probiotic dietary supplementation for promoting healthy kidney function in patients with chronic kidney disease. Adv Ther. 2010 Sep;27(9):634-47. doi: 10.1007/s12325-010-0059-9. Epub 2010 Aug 16.
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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.
Stephanie DeLoach, M.D. principal investigator
Thomas Jefferson University, Philadelphia, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Failure, run by Kibow Pharma at 1 site in United States.
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 4 inclusion and 6 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 18 Aug 2017. 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 United States. 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.
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?
15-20% Changes in BUN. (time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01450657, which also lists 2 linked publications.
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 18 Aug 2017.