A Phase 2 interventional study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetes Mellitus and Chronic Kidney Disease, sponsored by Prokidney. Completed at 4 sites in United States. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Prokidney · Phase 2, Interventional, and Treatment
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Among 3,304 studies in Diabetes Mellitus, Type 2 with a site in United States — 344 open to participants now, 478 under way, 51 of them phase 3. Diabetes Mellitus, Type 2 · United States.
Among the 3,304 studies in Diabetes Mellitus, Type 2 with a site in United States, this one is the 2,742nd largest by enrollment of the 2,957 interventional ones that give a count, is one of 126 that started in 2018, is one of 391 in phase 2, and was the 1,990th registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →344 of the 3,304 studies in Diabetes Mellitus, Type 2 with a site in United States are open now. Recruiting first, the newest first:
University of Minnesota · Sites in United States
Ages 30–75
Hoffmann-La Roche · Sites in United States, Puerto Rico
Ages 18+
Pfizer · Sites in United States
Ages 18+
Rahul Sachdeva · Sites in United States
Ages 18+ · Healthy volunteers
Amgen · Sites in United States, Canada
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 30 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,304 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 423 · Phase 2 464 · Phase 3 613 · Phase 4 300
First in 1976; this study’s year is marked. 126 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 90 across the 2,957 interventional studies, 128 across the 336 observational. Of the 2,648 that completed or were terminated, 1,165 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
1,486 of 3,304 have an industry lead sponsor. The 10 most frequent:
Prokidney is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Prokidney has 6 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
190 of the studies in Diabetes Mellitus, Type 2 with a site in United States that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06858878Phase 3AmgenEfficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT06731075Phase 3Oramed, Ltd.A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus. | 2027-04-25 |
| NCT07220759Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide | 2027-05-12 |
| NCT07817251Phase 3Novo Nordisk A/SResearch Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema | 2027-06-09 |
| NCT06993792Phase 3Eli Lilly and CompanyA Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes | 2027-08 |
Add all 190 to your calendar (.ics) → With an account.
Among the 3,304 studies in Diabetes Mellitus, Type 2 with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).
All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Biological: Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)
Procedure and/or Product Related Adverse Events
Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term
Time frame: Through 24 months following last REACT injection
Renal Specific Adverse Events
Percentage of subjects with renal-specific adverse events by System Order Class and Preferred Term
Time frame: Through 24 months following last REACT injection
| Milestone | Renal Autologous Cell Therapy (REACT) |
|---|---|
| Started | 10 |
| Completed | 3 |
| Not completed | 7 |
Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term
| percent of participants | Renal Autologous Cell Therapy (REACT) |
|---|---|
| All Body Systems | 70.0 |
| Renal and urinary disorders | 60.0 |
| renal haematoma | 30.0 |
| subcapsular renal hematoma | 20.0 |
| haematuria | 10.0 |
| perinephric collection | 10.0 |
| Blood and lymphatic system disorder | 10.0 |
| anaemia | 10.0 |
| General disorders and administration site conditions | 10.0 |
| fatigue | 10.0 |
| Injury, poisoning, and procedural complications | 10.0 |
| procedural pain | 10.0 |
Percentage of subjects with renal-specific adverse events by System Order Class and Preferred Term
| percent of participants | Renal Autologous Cell Therapy (REACT) |
|---|---|
| Renal and urinary disorders | 90.0 |
| End Stage Renal Disease | 50.0 |
| Renal haematoma | 40.0 |
| Acute Kidney Disease | 30.0 |
| Chronic Kidney Disease | 20.0 |
| Subcapsular renal haematoma | 20.0 |
| Haematuria | 10.0 |
| Hydronephrosis | 10.0 |
| perinephric collection | 10.0 |
Collected over the day of biopsy through 24 months after the final injection of REACT, approximately 33 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Renal Autologous Cell Therapy (REACT) | 2/10 (20%) | 8/10 (80%) | 10/10 (100%) |
| Event | Renal Autologous Cell Therapy (REACT) |
|---|---|
| ESRDRenal and urinary disorders | 4/10 |
| Acute kidney injuryRenal and urinary disorders | 2/10 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/10 |
| COVID-19Infections and infestations | 2/10 |
| Abdominal wall abscessInfections and infestations | 1/10 |
| AnemiaBlood and lymphatic system disorders | 1/10 |
| CellulitisInfections and infestations | 1/10 |
| Cerebrovascular accidentNervous system disorders | 1/10 |
| Chronic kidney diseaseRenal and urinary disorders | 1/10 |
| COVID-19 pneumoniaInfections and infestations | 1/10 |
| Event | Renal Autologous Cell Therapy (REACT) |
|---|---|
| ESRDRenal and urinary disorders | 5/10 |
| FatigueGeneral disorders | 4/10 |
| Urinary tract infectionInfections and infestations | 4/10 |
| DiarrheaGastrointestinal disorders | 4/10 |
| renal haematomaRenal and urinary disorders | 4/10 |
| Acute kidney injuryRenal and urinary disorders | 3/10 |
| Back painMusculoskeletal and connective tissue disorders | 3/10 |
| COVID-19Infections and infestations | 3/10 |
| DizzinessNervous system disorders | 3/10 |
| PyrexiaGeneral disorders | 3/10 |
| Age, Continuous(years) | Renal Autologous Cell Therapy (REACT) |
|---|---|
| Mean | 58.3 ± 5.03 |
| Sex: Female, Male(Participants) | Renal Autologous Cell Therapy (REACT) |
|---|---|
| Female | 5 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Renal Autologous Cell Therapy (REACT) |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Renal Autologous Cell Therapy (REACT) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| BMI (kg/m^2) at Screening,(kg/m^2) | Renal Autologous Cell Therapy (REACT) |
|---|---|
| Mean | 35.20 ± 8.415 |
| Volume (cm^3) - Treated kidney(cm^3) | Renal Autologous Cell Therapy (REACT) |
|---|---|
| Mean | 180.97 ± 76.077 |
| Volume (cm^3) - Untreated kidney(cm^3) | Renal Autologous Cell Therapy (REACT) |
|---|---|
| Mean | 163.93 ± 35.279 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Nov 2022, 54 months.
Results were first posted in Mar 2025, 2 years 4 months after primary completion.
Of 194 industry-sponsored phase 2 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 18. This study's 54 months is above that.
Counting every sponsor, half of 293 studies reached it within 15 months; a quarter within 11 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rilparencel
Prokidney