Type 2 Diabetes MellitusPhase 3NCT05286853
A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease
A Phase 3 study testing Renal Autologous Cell Therapy (REACT) in people with Type 2 Diabetes Mellitus and Chronic Kidney Diseases, run by Prokidney at 3 sites in Spain.
Trial summary
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Chronic Kidney Diseases
- What is being tested?
- Renal Autologous Cell Therapy (REACT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesSpain
- Study dates
- 17 Jul 2024to 3 Sep 2024
- Phase
- Phase 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant is male or female, 30 to 80 years of age on the date of informed consent.
- The participant has a clinical diagnosis of T2DM in their health record.
- The participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record.
- The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
- The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 44 mL/min/1.73m², not requiring renal dialysis.
- The participant has an urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g.
Who cannot join
- The participant has a history of type 1 diabetes mellitus.
- The participant has a history of renal transplantation.
- The participant has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening, across 3 measurements while seated.
- The participant has hemoglobin level less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
IMIM Hospital del Mar Medical Research Institute
Barcelona, 08003
Hospital Universitario Vall D'Hebron
Barcelona, 08035
Hospital Universitario 12 de Octubre
Madrid, 28026
About this study
Official title: A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
Read the detailed description
Randomized multi-center, blinded intervention, two cohort , study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will undergo sham procedures and be followed for 5 years post last simulated injection.. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed for 5 years post last injection of the investigational product.
- Conditions
- Type 2 Diabetes Mellitus, Chronic Kidney Diseases
- Being tested
- Renal Autologous Cell Therapy (REACT), Sham Comparator
- Keywords
- REACT, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Autologous Cell Therapy (REACT)Biological
Participants receiving institutional standard of care will have a kidney biopsy followed by 2 REACT injections into biopsied and non-biopsied contralateral kidneys 3 months (+30 days) apart and will be followed for 5 years (60 months) since last REACT injection.
Sham ComparatorProcedure or surgery
Participants receiving institutional standard of care will have 2 sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The second sham procedure will occur 3 months (+30 days) after the first sham procedure. Participants will be followed for 5 years (60 months) since last sham REACT injection.
| Study group | Role | What they receive |
|---|---|---|
| Sham Procedure | Sham comparator | Participants randomized to the Sham Comparator arm will have 2 sham procedures Receives: Procedure: Sham Comparator |
| Experimental (REACT injections) | Experimental | Participants randomized to the experimental arm will receive 2 injections of REACT. Receives: Biological: Renal Autologous Cell Therapy (REACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Composite Endpoint
The time from first injection to the earliest of:
- At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
- eGFR <15 mL/min/1.73m² using the 2009 serum creatinine equation, sustained for 30 days and/or chronic dialysis , and/or renal transplant or
- Renal or cardiovascular death
Measured: up to 60 Months post last injection of the investigational product or the last simulated injection.
Secondary outcomes (2)
First Secondary Endpoint: Time to progression of Chronic Kidney Disease
Time to progression of Chronic Kidney Disease
- At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
- eGFR <15mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or or
- Renal death
Measured: up to 60 Months post last injection of the investigational product or the last simulated injection
Second Secondary Endpoint: Time to End Stage Renal Disease
Time to End Stage Renal Disease
- eGFR, <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days. and/or chronic dialysis, and/or renal transplant or
- Renal death.
Measured: up to 60 Months post last injection of the investigational product or the last simulated injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start17 Jul 2024
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Why it stopped: Rilparencel is eligible for initial FDA/ RMAT approval pathway upon successful completion Phase3 REGEN006 (PROACT1) trial. Discontinued Phase3 REGEN016 (PROACT2) focused on enrollment outside the US and is not required for initial US registration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prokidney
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Prokidney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286853
- Sponsor's protocol ID
- REGEN-016
- Status last verified
- Jul 2024
- First submitted
- 24 Feb 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)
- ClinicalTrials.gov ID
- NCT05286853
- Acronym / sponsor ID
- REGEN-016
- Conditions
- Type 2 Diabetes Mellitus, Chronic Kidney Diseases
- Keywords
- REACT, Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Rilparencel is eligible for initial FDA/ RMAT approval pathway upon successful completion Phase3 REGEN006 (PROACT1) trial. Discontinued Phase3 REGEN016 (PROACT2) focused on enrollment outside the US and is not required for initial US registration.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ProkidneyIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 18 Mar 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.
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
Detailed description
Randomized multi-center, blinded intervention, two cohort , study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will undergo sham procedures and be followed for 5 years post last simulated injection.. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed for 5 years post last injection of the investigational product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Procedure | Sham comparator | Procedure: Sham ComparatorParticipants randomized to the Sham Comparator arm will have 2 sham procedures |
| Experimental (REACT injections) | Experimental | Biological: Renal Autologous Cell Therapy (REACT)Participants randomized to the experimental arm will receive 2 injections of REACT. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The participant is male or female, 30 to 80 years of age on the date of informed consent.
- The participant has a clinical diagnosis of T2DM in their health record.
- The participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record.
- The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
- The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 44 mL/min/1.73m², not requiring renal dialysis.
Key exclusion criteria (4 listed)
- The participant has a history of type 1 diabetes mellitus.
- The participant has a history of renal transplantation.
- The participant has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening, across 3 measurements while seated.
- The participant has hemoglobin level less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.
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 |
|---|---|---|
| Renal Autologous Cell Therapy (REACT)Participants receiving institutional standard of care will have a kidney biopsy followed by 2 REACT injections into biopsied and non-biopsied contralateral kidneys 3 months (+30 days) apart and will be followed for 5 years (60 months) since last REACT injection. | Biological | Experimental (REACT injections) |
| Sham ComparatorParticipants receiving institutional standard of care will have 2 sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The second sham procedure will occur 3 months (+30 days) after the first sham procedure. Participants will be followed for 5 years (60 months) since last sham REACT injection. | Procedure or surgery | Sham Procedure |
Primary outcome
Primary Composite Endpoint
Time frame: up to 60 Months post last injection of the investigational product or the last simulated injection.
The time from first injection to the earliest of: * At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or * eGFR <15 mL/min/1.73m² using the 2009 serum creatinine equation, sustained for 30 days and/or chronic dialysis , and/or renal transplant or * Renal or cardiovascular death
2 secondary outcomes
First Secondary Endpoint: Time to progression of Chronic Kidney Disease
Time frame: up to 60 Months post last injection of the investigational product or the last simulated injection
Second Secondary Endpoint: Time to End Stage Renal Disease
Time frame: up to 60 Months post last injection of the investigational product or the last simulated injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Study Director study director
Prokidney
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renal Autologous Cell Therapy (REACT) in people with Type 2 Diabetes Mellitus and Chronic Kidney Diseases, run by Prokidney at 3 sites 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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 25 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 3 sites 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. Some participants in this study may receive a placebo. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary Composite Endpoint (time frame: up to 60 Months post last injection of the investigational product or the last simulated injection.). 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 25 Sep 2024.