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NCT04278729
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome
Phase 1 trial testing Apixaban 5 MG in Nephrotic Syndrome in 22 participants. Completed in 22 September 2023.
22 September 2023
Quick facts
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 14 April 2021 |
| Primary completion | 22 September 2023 |
| Estimated completion | 22 September 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Apixaban 5 MG — full drug profile →
Conditions studied
- Nephrotic Syndrome — all drugs for Nephrotic Syndrome →
- Membranous Nephropathy — all drugs for Membranous Nephropathy →
Sponsor
University of North Carolina, Chapel Hill
Who can join
Adults 18 to 79, any sex, with Nephrotic Syndrome or Membranous Nephropathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I study is a single arm, multi-dose study that will evaluate steady-state apixaban pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with Nephrotic Syndrome (NS) vs healthy control subjects. This study will enroll 20 subjects diagnosed with NS and 10 healthy control subjects. Comparing differences in steady-state apixaban PK/PD parameters between subjects with NS and healthy volunteers will be essential to identifying a safe and effective apixaban dose and dose administration schedule for future randomized controlled trials (RCTs).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Thromboembolism in nephrotic syndrome: controversies and uncertainties.
Parker K, Ragy O, Hamilton P, Thachil J, et al · · 2023 · cited 23× · PMID 37680313 · DOI 10.1016/j.rpth.2023.102162 -
Pharmacokinetics and Pharmacodynamics of Apixaban in Nephrotic Syndrome: Findings From a Phase 1a Trial.
Derebail VK, Zhu J, Crawford ML, Garnier JR, et al · · 2023 · cited 9× · PMID 36328100 · DOI 10.1053/j.ajkd.2022.09.011 -
Challenges and Opportunities of Direct Oral Anticoagulant (DOAC) Therapy in Complex Clinical Scenarios: A Comprehensive Review and Practical Guide.
Miceli G, Ciaccio AM, Tuttolomondo A. · · 2025 · cited 6× · PMID 40363949 · DOI 10.3390/jcm14092914 -
UK prescribing practice of anticoagulants in patients with chronic kidney disease: a nephrology and haematology-based survey.
Parker K, Choudhuri S, Lewis P, Thachil J, et al · · 2023 · cited 6× · PMID 36635661 · DOI 10.1186/s12882-022-03041-w -
Anticoagulation for the Prevention of Thrombotic Events in Nephrotic Syndrome.
Azarniouch DM, Crona DJ, Karnabi P, Bose B, et al · · 2024 · cited 2× · PMID 39430178 · DOI 10.1016/j.ekir.2024.07.013 -
UK prescribing practice of anticoagulants in patients with chronic kidney disease: A nephrology and haematology-based survey
Parker K, Choudhuri S, Lewis P, Thachil J, et al · · 2022 · DOI 10.21203/rs.3.rs-2131328/v1
Verify or expand the search:
- PubMed search for NCT04278729
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other recruiting trials for Nephrotic Syndrome
Currently open trials in the same condition.
- NCT07214818 — SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome · Phase 2, PHASE3 · active not recruiting
- NCT06635720 — REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE (RESPONSE) · Phase 3 · recruiting
- NCT06622915 — Cardiac Performance Evaluation in Children With Steroid Dependent vs Steroid Resistant Nephrotic Syndrome · NA · recruiting
- NCT06161701 — Steroid Diabetes in Patients With Kidney Disease · recruiting
- NCT06373913 — The Role of Proprotein-convertase-subtilisin/Kexin-type 9 in Kidney Damage in Nephrotic Syndrom · recruiting
Other University of North Carolina, Chapel Hill trials
Trials by the same sponsor.
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- NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
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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 NCT04278729 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
- Last refreshed: 26 September 2023
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/NCT04278729.
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