Last reviewed · How we verify
NCT07017933: GRADIENT
Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
NA trial testing Renal assist device in Renal Impairment After Cardiac Surgery in 124 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | 3ive Labs |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 124 |
| Start date | 16 July 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 14 June 2027 |
| Sites | 7 locations across United States, Poland |
Drugs / interventions tested
- Renal assist device
Conditions studied
- Renal Impairment After Cardiac Surgery — all drugs for Renal Impairment After Cardiac Surgery →
- Renal Impairment — all drugs for Renal Impairment →
- Acute Kidney Injury — all drugs for Acute Kidney Injury →
Sponsor
3ive Labs — full company profile →
Who can join
Adults 22 to 85, any sex, with Renal Impairment After Cardiac Surgery or Renal Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with renal insufficiency who undergo cardiac surgery with cardiopulmonary bypass (CPB) are at significant risk for exacerbation of renal dysfunction postoperatively. This in turn is associated with an increased risk of prolonged intensive care unit (ICU) length of stay, other comorbidities including surgical complications and 30-day mortality. Renal impairment is generally identified based on an increase in serum creatinine concentration and/or a certain magnitude decrease in estimated glomerular filtration rate (eGFR). The JuxtaFlow® Renal Assist Device (RAD) is designed to sustain or enhance glomerular filtration perioperatively for patients with renal insufficiency by applying a mild controlled negative pressure to the collecting system via the renal pelvis, thereby increasing effective filtration pressure and reducing tubular pressure. This mechanism is designed to support the kidneys' functions during times of renal stress that would be associated with intrarenal edema, volume overload, increased venous pressure, and inflammatory response. By supporting renal function, specifically during the acute stress of CPB, JuxtaFlow holds promise to protect nephron function, decrease renal hypoxia, and provide multifactorial kidney function support to maintain their ability to manage future stress.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07017933
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other 3ive Labs trials
Trials by the same sponsor.
- NCT05990660 — Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery · NA · completed
- NCT04227977 — Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF) · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07017933 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by 3ive Labs
- Last refreshed: 19 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07017933.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing