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NCT03546205
A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function
Phase 1 trial testing JNJ-64565111 in Kidney Failure, Chronic in 40 participants. Completed in 17 December 2018.
17 December 2018
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 40 |
| Start date | 6 June 2018 |
| Primary completion | 17 December 2018 |
| Estimated completion | 17 December 2018 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- JNJ-64565111 — full drug profile →
Conditions studied
- Kidney Failure, Chronic — all drugs for Kidney Failure, Chronic →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
Adults 18 to 79, any sex, with Kidney Failure, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of study is to evaluate the pharmacokinetics of a single, subcutaneous dose of JNJ-64565111 in adult participants with varying degrees of renal function including participants with end stage renal disease, requiring hemodialysis, compared with participants with normal renal function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03546205
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of JNJ-64565111
Trials testing the same drug.
- NCT03618160 — A Study to Assess the Safety, Tolerability and Pharmacokinetics of Subcutaneous (SC) Injections of JNJ-64565111 in Healt · Phase 1 · terminated
- NCT03606057 — A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placeb · Phase 1 · completed
- NCT03586843 — A Study of JNJ-64565111 After Single Subcutaneous Administration at Different Injection Sites in Otherwise Healthy Overw · Phase 1 · completed
- NCT03235219 — A Phase 1b Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of JNJ-64565111 · Phase 1 · completed
- NCT02862431 — Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Type 2 Diabetes Mellitus · Phase 1 · terminated
Other recruiting trials for Kidney Failure, Chronic
Currently open trials in the same condition.
- NCT06903559 — Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients · Phase 1, PHASE2 · recruiting
- NCT06438445 — Effects of Royal Jelly Supplementation in Chronic Kidney Disease · NA · recruiting
- NCT06288451 — DePTH: De-emphasize PTH · Phase 2 · active not recruiting
- NCT05968391 — Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP) · recruiting
- NCT06314503 — First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients · NA · recruiting
Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
- NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · 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 NCT03546205 (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 Janssen Research & Development, LLC
- Last refreshed: 27 April 2025
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/NCT03546205.
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