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NCT05181969: LOLIDA
Long-term Characterization of Lipoprotein Apheresis Technologies for Individual Device Adaption (LOLIDA)
trial testing Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV) in Lipoproteinemia in 500 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | Technische Universität Dresden |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 1 October 2014 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Dextran sulfate absorption (LIPOSORBER® D - Kaneka Pharma Europe NV)
- Lipid filtration (Octo Nova®, Diamed Medizintechnik)
- Direct absorption of lipoproteins (DALI®; ADS 4008, Fresenius)
- Therasorb (TheraSorb® - LDL adsorbers, Miltenyi Biotec)
Conditions studied
- Lipoproteinemia — all drugs for Lipoproteinemia →
- Apheresis Related Complication — all drugs for Apheresis Related Complication →
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
Sponsor
Technische Universität Dresden — full company profile →
Who can join
Eligibility, any sex, with Lipoproteinemia or Apheresis Related Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Lipoprotein apheresis is often applied as the final treatment of patient with severe and medication resistant dyslipidemia and progressive atherosclerosis. The high effectiveness of lipoprotein apheresis to improve the patient's metabolic situation and thereby strongly minimize the incidence of cardiovascular events was confirmed by a variety of studies. While in the past years, mostly patients with severe homo- or heterozygous familial hypercholesterolemia (FH) or otherwise highly elevated LDL-cholesterol were subjected to lipoprotein apheresis, currently the major indication for lipoprotein apheresis is a critical elevated plasma level of lipoprotein (a) \[Lp(a)\] in patients with severe cardiovascular events. Even if it is now widely accepted that Lp(a) is an independent risk factor for cardiovascular diseases due to its pro-atherogenic potential, the exact molecular mechanisms by which Lp(a) contributes to the atherosclerotic process remain unclear. Despite rigorous reduction of plasma Lp(a)-levels during lipoprotein apheresis newly occurring cardiovascular events cannot prevented in all patients. Specific pleiotropic effects of apheresis technologies are supposed to be critically involved in the clinical outcome. By measurement of a wide variety of cardio-metabolic biomarkers playing a role in inflammation, endothelial dysfunction, lipid metabolism or blood pressure regulation during repeated Lp(a) lowering by various apheresis methods may allow the identification of clusters of risk factors determining clinical outcome and give the biological basement for an optimized individual lipoprotein apheresis therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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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 NCT05181969 (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 Technische Universität Dresden
- Last refreshed: 10 January 2022
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