The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
CAPTIVATE: Chronic Kidney Disease Treatment Trial
Plain English Summary
The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect is a Phase 3 clinical trial sponsored by The George Institute studying Chronic Kidney Diseases. Tests various drugs to slow CKD progression For adults with chronic kidney disease Participation involves taking daily medication and regular check-ups Alternatives include standard care and other clinical trials The trial aims to enroll 1000 participants.
Official Summary
CAPTIVATE is an international, multi-centre, Phase III, adaptive, platform, randomised controlled trial in people with chronic kidney disease (CKD). CAPTIVATE aims to find the best treatment, or combination of treatments, that slow the progression of CKD so that fewer people develop kidney failure. CAPTIVATE provides a research platform that allows many treatment-related questions to be answered within a common trial set-up.
Who Can Participate
Here is what you need to know about eligibility for this trial. Ages 18 and older Chronic kidney disease from any cause Currently on standard care treatment Willing to participate in at least one treatment domain This trial is studying Chronic Kidney Diseases, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well the treatment slows kidney function decline over time. The specific primary outcome measures are: eGFR slope (From randomisation to week 108). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to find the best treatment for chronic kidney disease, filling a gap in current care options. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Chronic Kidney Diseases, where improved treatment options are needed.
Investor Insight
Market size is large, with strong competition; approval probability is moderate given the need for effective CKD treatments. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 1000 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about your eligibility and the potential benefits and risks. Daily participation involves taking medication and attending regular clinic visits. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: FACTORIAL
- Masking: QUADRUPLE
- Enrollment: 1,000 participants
Interventions
- DRUG: Finerenone — Finerenone 10mg or 20mg tablets, oral, once daily
- DRUG: Placebo Finerenone — Finerenone matched placebo tablets, oral, once daily
Primary Outcomes
- eGFR slope (From randomisation to week 108)
Secondary Outcomes
- Change in albuminuria (From randomisation to week 24)
- Composite of 40% eGFR decline or kidney failure (From randomisation to week 108)
- All-cause mortality at 108 weeks (108 weeks)
- Number of cardiovascular events (108 weeks)
- Safety and tolerability of treatment (108 weeks)
Full Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2) 3. Currently receiving standard of care treatment according to treating physician 4. Eligible for randomisation in at least one recruiting domain-specific appendix 5. Participant and treating physician are willing and able to perform trial procedures Exclusion Criteria: 1. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months 2. Life expectancy less than 6 months
Trial Locations
- The Canberra Hospital, Garran, Australian Capital Territory, Australia
- Nepean Blue Mountains Local Health District, Kingswood, New South Wales, Australia
- St George Hospital, Kogarah, New South Wales, Australia
- John Hunter Hospital, New Lambton Heights, New South Wales, Australia
- Westmead Hospital, Westmead, New South Wales, Australia
- Sunshine Coast Hospital and Health Service, Birtinya, Queensland, Australia
- Townsville University Hospital, Douglas, Queensland, Australia
- West Moreton Hospital & Health Service, Ipswich, Queensland, Australia
- Gold Coast Hospital and Health Service, Southport, Queensland, Australia
- Royal Adelaide, Adelaide, South Australia, Australia
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06058585?
NCT06058585 is a Phase 3 INTERVENTIONAL study titled "The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect." It is currently recruiting and is sponsored by The George Institute. The trial targets enrollment of 1000 participants.
What conditions does NCT06058585 study?
This trial investigates treatments for Chronic Kidney Diseases. The primary condition under study is Chronic Kidney Diseases.
What treatments are being tested in NCT06058585?
The interventions being studied include: Finerenone (DRUG), Placebo Finerenone (DRUG). Finerenone 10mg or 20mg tablets, oral, once daily
What does Phase 3 mean for NCT06058585?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06058585?
This trial is currently "Recruiting." It started on 2024-09-04. The estimated completion date is 2029-03-31.
Who is sponsoring NCT06058585?
NCT06058585 is sponsored by The George Institute. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06058585?
The trial aims to enroll 1000 participants. The trial is currently recruiting and accepting new participants.
How is NCT06058585 designed?
This is a interventional study, uses randomized allocation, follows a factorial design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06058585?
The primary outcome measures are: eGFR slope (From randomisation to week 108). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06058585 being conducted?
This trial is being conducted at 20 sites, including Garran, Australian Capital Territory; Kingswood, New South Wales; Kogarah, New South Wales; New Lambton Heights, New South Wales and 16 more sites (Australia, India).
Where can I find official information about NCT06058585?
The official record for NCT06058585 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06058585. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06058585 testing in simple terms?
Tests various drugs to slow CKD progression For adults with chronic kidney disease
Why is this trial significant?
This trial aims to find the best treatment for chronic kidney disease, filling a gap in current care options. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06058585?
Possible side effects include nausea, headache, and changes in blood pressure. Monitor your health closely and report any issues to the research team. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06058585?
Ask your doctor about your eligibility and the potential benefits and risks. Daily participation involves taking medication and attending regular clinic visits. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06058585 signal from an investment perspective?
Market size is large, with strong competition; approval probability is moderate given the need for effective CKD treatments. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves taking daily medication and regular check-ups Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Chronic Kidney Diseases Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.