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NCT05834777
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
Phase 3 trial testing Icatibant in Intradialytic Hypotension in 26 participants. Currently enrolling.
1 July 2026
Quick facts
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | health services research |
| Enrollment | 26 |
| Start date | 11 December 2023 |
| Primary completion | 1 July 2026 |
| Estimated completion | 1 November 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Icatibant (ICATIBANT) — full drug profile →
- Placebo
Conditions studied
- Intradialytic Hypotension — all drugs for Intradialytic Hypotension →
Sponsor
Vanderbilt University Medical Center
Who can join
Adults 18 to 80, any sex, with Intradialytic Hypotension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Currently, there is no medication available to adequately treat patients undergoing hemodialysis who are suffering from intradialytic hypotension (IDH). Medical interventions such as Trendelenburg positioning, saline bolus administration, reduction of ultrafiltration rate, interruption of the hemodialysis, and other medical treatments are the methods of choice to treat the hypotensive condition of these patients and thus to maintain the systolic blood pressure. Patients suffering from IDH have a higher reported mortality rate due to the given stress on their cardiovascular system. New treatments, therefore, would give clinicians an additional alternative to current existing approaches and might help patients to maintain their blood pressure during hemodialysis. The main objective of the study is to evaluate the efficacy of icatibant in the prevention of systolic blood pressure (SBP) drop in patients on hemodialysis suffering from recurrent IDH episodes during hemodialysis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05834777
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Icatibant
Trials testing the same drug.
- NCT05509569 — A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema · completed
- NCT05407597 — Inhibition of Bradykinin in COVID-19 Infection With Icatibant · Phase 2, PHASE3 · completed
- NCT04488081 — I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients · Phase 2 · active not recruiting
- NCT04113109 — Mechanisms Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 2 · Phase 4 · completed
- NCT03177798 — Mitochondria and Chronic Kidney Disease · Phase 2 · completed
Other recruiting trials for Intradialytic Hypotension
Currently open trials in the same condition.
- NCT07179705 — Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients · NA · recruiting
- NCT07033260 — Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension · recruiting
- NCT07022847 — Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis · recruiting
- NCT07033273 — Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension · recruiting
- NCT05814146 — Trial of Variable Dialysate Bicarbonate · NA · recruiting
Other Vanderbilt University Medical Center trials
Trials by the same sponsor.
- NCT07005037 — Swallowing Impairments in ICU Survivors and Community-Dwelling Adults · not yet recruiting
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- NCT07224711 — The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery · Phase 4 · not yet recruiting
- NCT07431541 — Topical Carboxytherapy Paste Following Microneedling · Phase 1, PHASE2 · not yet recruiting
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 NCT05834777 (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 Vanderbilt University Medical Center
- Last refreshed: 15 April 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/NCT05834777.
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