Chronic Kidney Disease stage4Phase 2/3NCT05407389
Rollover Extension Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study
A Phase 2/3 study testing KT-301 (formerly US-APR2020) in people with Chronic Kidney Disease stage4, run by Kibow Pharma at 5 sites in United States.
Trial summary
This is an Open-Label Rollover Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of KT-301 (formerly US-APR2020) in Subjects With CKD IV Who Completed the US-APR2020-01 Study Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease stage4
- What is being tested?
- KT-301 (formerly US-APR2020)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Apr 2022to Mar 2026
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of US-APR2020-01 study
- Adults between the ages of 18-80 years
Who cannot join
- Did not participate in the placebo-controlled study US-APR2020-01
- Withdrew from US-APR2020-01 study prior to completing the 6 months treatment for any reason
- Unwilling or unable to visit the site for the follow-up visits
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Almeda Medical Clinic
Houston, Texas, 77058
South Carolina Clinical Research
Orangeburg, South Carolina, 29118
Kidney Michigan
Saginaw, Michigan, 48604
Jadedstone Clinical Research
Silver Spring, Maryland, 20904
Mendez Center for Clinical Research
Woodbridge, Virginia, 22192
About this study
Official title: An Open-Label Rollover Extension Phase 2 Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study
This is an Open-Label Rollover Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of KT-301 (formerly US-APR2020) in Subjects With CKD IV Who Completed the US-APR2020-01 Study
Read the detailed description
Kidney diseases are a global public health problem that affects over 200 million people worldwide. It is estimated that about 30 million adults in the United States have Chronic Kidney Disease (CKD) and most are undiagnosed. In addition, CKD represents the ninth leading cause of death in the United States. Kidney diseases also represent great socioeconomical cost worldwide. In the United States, treating Medicare beneficiaries with CKD costed over $79 billion, and treating people with End Stage Kidney Disease (ESKD) costed an additional $35 billion in 2016. To date, there is no cure for CKD.
CKD is accompanied by altered pathogenic gut bacteria, inflammation, and accumulation of uremic toxins in the blood. These blood uremic toxins can diffuse passively into the bowel. Scientific research has shown that probiotic bacteria could metabolize various uremic toxins such as urea, uric acid and creatinine. In addition, by supplementing the gut microbiome with probiotic bacteria, it is possible to metabolize the nitrogenous waste products and other toxins which diffuse into the gut, and thus lower levels of inflammation and blood uremic toxins.
KT-301 (formerly US-APR2020) is a probiotic formulation of bacteria intended to restore the gut bacteria balance to improve the removal of uremic toxins in the bowel in CKD patients.
This is an open label, multicenter, rollover extension study to provide KT-301 to subjects who were previously enrolled into and completed the placebo-controlled study, US-APR2020-01. Subjects will roll over to the long-term extension study at the last visit of the US-APR-2020-01 study. All subjects who completed the US-APR2020-01 study will be eligible to enroll in this study.
The purpose of this open-label study is to evaluate the long-term safety and efficacy of the live biotherapeutic product, KT-301, in the management of patients with CKD Stage IV.
- Conditions
- Chronic Kidney Disease stage4
- Being tested
- KT-301 (formerly US-APR2020)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KT-301 (formerly US-APR2020)Drug
KT-301 (formerly US-APR2020) will be administered orally at 2 capsules per day (a total dose of 90 Billion CFUs per day of the Live BioTherapeutic).
| Study group | Role | What they receive |
|---|---|---|
| KT-301 (formerly US-APR2020) | Experimental | Not described Receives: Drug: KT-301 (formerly US-APR2020) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the long-term safety of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV
Presence of adverse events in less than 10% of the study population, as a measure of safety Chronic Kidney Disease (CKD) Stage IV
Measured: 6 months
Evaluate the clinical efficacy of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV
Arresting the decline of eGFR as per NKF-USFDA guidelines following date of roll- over transition until study competition, compared to baseline (End of study for US- APR2020-01) as a measure of clinical efficacy
Measured: 6 months
Secondary outcomes (4)
Evaluate changes in basic blood uremic metabolic markers
Measured: 6 months
Evaluate changes in complete blood count and hematology parameters
Measured: 6 months
Reduction in C-Reactive Protein (CRP) levels following date of roll-over transition until study competition
Measured: 6 months
Percent change in rating scale (Modified SF36 QOL questionnaire) from roll-over transition until study competition (at 24-weeks)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start21 Apr 2022
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Why it stopped: Logistics, company reorganization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage4Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an extension open-label multicenter study to evaluate the long-term safety and efficacy of KT-301 (formerly US-APR2020) in patients with CKD Stage IV. KT-301 will be administered orally at 2 capsules per day (a total dose of 90 Billion CFUs per day of the Live BioTherapeutic).
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kibow Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407389
- Sponsor's protocol ID
- US-APR2020-02
- Status last verified
- Sep 2024
- First submitted
- 27 May 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Rollover Extension Phase 2 Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study
- ClinicalTrials.gov ID
- NCT05407389
- Acronym / sponsor ID
- US-APR2020-02
- Conditions
- Chronic Kidney Disease stage4
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Logistics, company reorganization.
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kibow PharmaIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 7 Jun 2022 (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.
This is an Open-Label Rollover Extension Clinical Trial to Evaluate the Long-Term Safety and Efficacy of KT-301 (formerly US-APR2020) in Subjects With CKD IV Who Completed the US-APR2020-01 Study
Detailed description
Kidney diseases are a global public health problem that affects over 200 million people worldwide. It is estimated that about 30 million adults in the United States have Chronic Kidney Disease (CKD) and most are undiagnosed. In addition, CKD represents the ninth leading cause of death in the United States. Kidney diseases also represent great socioeconomical cost worldwide. In the United States, treating Medicare beneficiaries with CKD costed over $79 billion, and treating people with End Stage Kidney Disease (ESKD) costed an additional $35 billion in 2016. To date, there is no cure for CKD.
CKD is accompanied by altered pathogenic gut bacteria, inflammation, and accumulation of uremic toxins in the blood. These blood uremic toxins can diffuse passively into the bowel. Scientific research has shown that probiotic bacteria could metabolize various uremic toxins such as urea, uric acid and creatinine. In addition, by supplementing the gut microbiome with probiotic bacteria, it is possible to metabolize the nitrogenous waste products and other toxins which diffuse into the gut, and thus lower levels of inflammation and blood uremic toxins.
KT-301 (formerly US-APR2020) is a probiotic formulation of bacteria intended to restore the gut bacteria balance to improve the removal of uremic toxins in the bowel in CKD patients.
This is an open label, multicenter, rollover extension study to provide KT-301 to subjects who were previously enrolled into and completed the placebo-controlled study, US-APR2020-01. Subjects will roll over to the long-term extension study at the last visit of the US-APR-2020-01 study. All subjects who completed the US-APR2020-01 study will be eligible to enroll in this study.
The purpose of this open-label study is to evaluate the long-term safety and efficacy of the live biotherapeutic product, KT-301, in the management of patients with CKD Stage IV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an extension open-label multicenter study to evaluate the long-term safety and efficacy of KT-301 (formerly US-APR2020) in patients with CKD Stage IV. KT-301 will be administered orally at 2 capsules per day (a total dose of 90 Billion CFUs per day of the Live BioTherapeutic).
| Arm | Type | Receives |
|---|---|---|
| KT-301 (formerly US-APR2020) | Experimental | Drug: KT-301 (formerly US-APR2020) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completion of US-APR2020-01 study
- Adults between the ages of 18-80 years
Key exclusion criteria (3 listed)
- Did not participate in the placebo-controlled study US-APR2020-01
- Withdrew from US-APR2020-01 study prior to completing the 6 months treatment for any reason
- Unwilling or unable to visit the site for the follow-up visits
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 |
|---|---|---|
| KT-301 (formerly US-APR2020)KT-301 (formerly US-APR2020) will be administered orally at 2 capsules per day (a total dose of 90 Billion CFUs per day of the Live BioTherapeutic). | Drug | KT-301 (formerly US-APR2020) |
Primary outcome
Evaluate the long-term safety of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV
Time frame: 6 months
Presence of adverse events in less than 10% of the study population, as a measure of safety Chronic Kidney Disease (CKD) Stage IV
Evaluate the clinical efficacy of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV
Time frame: 6 months
Arresting the decline of eGFR as per NKF-USFDA guidelines following date of roll- over transition until study competition, compared to baseline (End of study for US- APR2020-01) as a measure of clinical efficacy
4 secondary outcomes
Evaluate changes in basic blood uremic metabolic markers
Time frame: 6 months
Evaluate changes in complete blood count and hematology parameters
Time frame: 6 months
Reduction in C-Reactive Protein (CRP) levels following date of roll-over transition until study competition
Time frame: 6 months
Percent change in rating scale (Modified SF36 QOL questionnaire) from roll-over transition until study competition (at 24-weeks)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Chronic Kidney Disease stage4
RecruitingObservational study
Feasibility of Estimating the Prevalence and Management of Stage 4 CKD the Gard, France
Renal Insufficiency, Chronic
RecruitingObservational study
Hyperlipoproteinemia A as a Marker of Cardiovascular Risk in Patients With Stage 4 Chronic Kidney Disease
CKD, Cardiovascular Diseases
Not yet recruiting
Feasibility of the COMFORT (COmplex Symptom Management Intervention FOR adulTs With Advanced Kidney Disease) Intervention for Adults With Advanced Kidney Disease and Their Informal Caregivers
Chronic Kidney Disease (Stages 4 and 5)
Recruiting
A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced CKD and Clinicians
Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5
RecruitingPhase 2
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
CKD Stage 3, CKD Stage 4
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing KT-301 (formerly US-APR2020) in people with Chronic Kidney Disease stage4, run by Kibow Pharma at 5 sites 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 2 inclusion and 3 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: paused, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Evaluate the long-term safety of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV (time frame: 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?
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 19 Sep 2024.