An observational study in Diabetic Kidney Disease and Chronic Kidney Disease, sponsored by Prokidney. Enrolling by invitation at 1 site in United States. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Prokidney · Observational
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Among 153 studies in Diabetic Nephropathies with a site in United States — 22 open to participants now, 32 under way, 1 of them phase 3. Diabetic Nephropathies · United States.
Among the 153 studies in Diabetic Nephropathies with a site in United States, this one is the 25th largest by planned enrollment of the 31 observational ones that give a count, is one of 7 that started in 2023, is one of 31 observational ones, reaches primary completion later than 28 of the 30 other live ones, and was the 144th registered.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
Browse Diabetic Nephropathies studies →22 of the 153 studies in Diabetic Nephropathies with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Ages 18–80
Medical University of South Carolina · Sites in United States
Ages 18–75
University of Pennsylvania · Sites in United States
Ages 18+ · Healthy volunteers
AstraZeneca · Sites in United States
Ages 18–75 · Healthy volunteers
Seattle Children's Hospital · Sites in United States
Ages 14–40
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 50 Diabetic Nephropathies studies recruiting now, 23 (46%) set no upper age limit and 16 (32%) stop at 75 or younger; 5 take children under 18; 8 take healthy volunteers.
This study: 30 Years to 80 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.
153 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 21 · Phase 2 61 · Phase 3 16 · Phase 4 10
First in 1981; this study’s year is marked. 7 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 188 across 138 observational studies indexed under Diabetic Nephropathies.
Median enrollment 79 across the 120 interventional studies, 175 across the 31 observational. Of the 115 that completed or were terminated, 46 (40%) have results posted.
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70 of 153 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 3 studies filed under Diabetic Nephropathies — fewer than ten, so there is no comparison to draw.
12 of the studies in Diabetic Nephropathies with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05759468Brigham and Women's HospitalNAD Augmentation in Diabetes Kidney Disease | 2026-11-30 |
| NCT07022418Medical University of South CarolinaFormoterol in Diabetes | 2026-12 |
| NCT04802395Renalytix AI, Inc.Real World Evidence Clinical Utility Study of KidneyIntelX | 2026-12-01 |
| NCT05507892University of Colorado, DenverRenal Mechanism of SGLT2 Inhibition | 2026-12-15 |
| NCT07024823AstraZenecaA Study to Investigate Safety, Tolerability, PK, and PD of AZD4248 in Healthy Participants, Participants With CKD and Type 2 Diabetes, Assess Home Measurements of Creatinine in a Non-Interventional Cohort, and Assess the Effect of AZD4248 on the PK of Midazolam and Metformin in Healthy Participants | 2027-01-29 |
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Among the 153 studies in Diabetic Nephropathies with a site in United States, from their registry updates:
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The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.
This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 50 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (REGEN-007, REGEN-006, REGEN-015) will be monitored for up to five years with alternating in clinic and phone visits.
Patients with Chronic Kidney Disease
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.
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.
Participants Exposed to Renal Autologous Cell Therapy from studies REGEN-007, REGEN-006, REGEN-015 (REGEN-008S2).
Biological: Renal Autologous Cell Therapy (REACT)
No interventions in this trial
Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies.
Evaluation of the long-term safety of REACT will be assessed via: * Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. * Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. * Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. * Incidence of delayed investigational product related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
Time frame: 60 months from completion of parent protocol EOS Visit
Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation.
Time from first injection to eGFR \<15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation.
Time frame: 60 months from completion of parent protocol EOS Visit
Time from first injection to chronic dialysis.
Time from first injection to chronic dialysis
Time frame: 60 months from completion of parent protocol EOS Visit
Time from first injection to renal transplant
Time from first injection to renal transplant
Time frame: 60 months from completion of parent protocol EOS Visit
Time from first injection to a cardiovascular death.
Time from first injection to a cardiovascular death.
Time frame: 60 months from completion of parent protocol EOS Visit
Time from first injection to a renal death.
Time from first injection to a renal death.
Time frame: 60 months from completion of parent protocol EOS Visit
Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD) at Months 12, 24, 36, 48, and 60.
Percent of participants who have the same or reduced 5-year risk of end stage renal
Time frame: 60 months from completion of parent protocol EOS Visit
Percent of participants who have the same or reduced 2-year risk of end stage renal disease at Months 12, 24, 36, 48, and 60.
Percent of participants who have the same or reduced 2-year risk of end stage renal
Time frame: 60 months from completion of parent protocol EOS Visit
Started Nov 2023 (actual). Primary completion is estimated for May 2030, 78 months after the start.
Of 38 observational studies under Diabetic Nephropathies, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 25. This study's planned 78 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Prokidney