NCT02248051

An Open-Label, Non-Randomized Study of Safety, Tolerability and Pharmacokinetics of Intravenous CXA-10 Emulsion in Subjects With Stage 3 and 4 Chronic Kidney Injury

Completed Phase 1 Last updated 30 January 2018

What this trial tests

Phase 1 trial testing CXA-10 in Acute Kidney Injury (Nontraumatic) in 12 participants. Completed in 1 September 2015.

Timeline

1 September 2014

Primary endpoint
1 August 2015

1 September 2015

Quick facts

Lead sponsor	Complexa, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 September 2014
Primary completion	1 August 2015
Estimated completion	1 September 2015
Sites	2 locations across United States

Drugs / interventions tested

• CXA-10 — full drug profile →

Conditions studied

• Acute Kidney Injury (Nontraumatic) — all drugs for Acute Kidney Injury (Nontraumatic) →

Sponsor

Complexa, Inc. — full company profile →

Who can join

Adults 18 to 70, any sex, with Acute Kidney Injury (Nontraumatic). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of subjects with Serious and Non-Serious Adverse Events
  Time frame: First day of dosing through 30 days
  Safety assessments will be performed prior to, during, and after dosing including a visit on Day 18

Sponsor's own description

The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient population comprised of subjects with Stage 3 and 4 chronic kidney injury (CKI). In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Activators and Inhibitors of NRF2: A Review of Their Potential for Clinical Development.
   Robledinos-Antón N, Fernández-Ginés R, Manda G, Cuadrado A. · · 2019 · cited 443× · PMID 31396308 · DOI 10.1155/2019/9372182
2. Nitro-fatty acids protect against steatosis and fibrosis during development of nonalcoholic fatty liver disease in mice.
   Rom O, Xu G, Guo Y, Zhu Y, et al · · 2019 · cited 51× · PMID 30772307 · DOI 10.1016/j.ebiom.2019.02.019
3. Nitro-fatty acids in cardiovascular regulation and diseases: characteristics and molecular mechanisms.
   Villacorta L, Gao Z, Schopfer FJ, Freeman BA, et al · · 2016 · cited 42× · PMID 26709810 · DOI 10.2741/4425
4. Early aging and premature vascular aging in chronic kidney disease.
   Tanriover C, Copur S, Mutlu A, Peltek IB, et al · · 2023 · cited 34× · PMID 37915901 · DOI 10.1093/ckj/sfad076
5. Inflammatory signaling and metabolic regulation by nitro-fatty acids.
   Rom O, Khoo NKH, Chen YE, Villacorta L. · · 2018 · cited 17× · PMID 29578057 · DOI 10.1016/j.niox.2018.03.017
6. Insights on Localized and Systemic Delivery of Redox-Based Therapeutics.
   Buglak NE, Batrakova EV, Mota R, Bahnson ESM. · · 2018 · cited 9× · PMID 29636836 · DOI 10.1155/2018/2468457
7. Structural Modifications Yield Novel Insights Into the Intriguing Pharmacodynamic Potential of Anti-inflammatory Nitro-Fatty Acids.
   Hellmuth N, Brat C, Awad O, George S, et al · · 2021 · cited 8× · PMID 34867322 · DOI 10.3389/fphar.2021.715076
8. Nitro-fatty acids decrease type I interferons and monocyte chemoattractant protein 1 in ex vivo models of inflammatory arthritis.
   Hansen AL, Rahbek LSJ, Sørensen AS, Hundahl MP, et al · · 2021 · cited 6× · PMID 34920714 · DOI 10.1186/s12865-021-00471-3