An observational study in End-stage Renal Disease and Critical Limb Ischemia, sponsored by University Hospital Erlangen. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by University Hospital Erlangen · Observational
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Among 109 studies in Kidney Failure, Chronic with a site in Germany — 9 open to participants now, 15 under way, 4 of them phase 3. Kidney Failure, Chronic · Germany.
Among the 109 studies in Kidney Failure, Chronic with a site in Germany, this one is the 14th largest by enrollment of the 23 observational ones that give a count, is one of 7 that started in 2017, is one of 23 observational ones, and was the 78th registered.
2,109 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
Browse Kidney Failure, Chronic studies →9 of the 109 studies in Kidney Failure, Chronic with a site in Germany are open now. Recruiting first, the newest first:
CSL Behring · Sites in Germany, United States, Argentina and 32 more countries
Ages 18+
W.L.Gore & Associates · Sites in Germany, Italy, United Kingdom
Ages 18+
Iperboreal Pharma Srl · Sites in Germany, Denmark, Italy and 3 more countries
Ages 18+
Dicerna Pharmaceuticals, Inc., a Novo Nordisk company · Sites in Germany, United States, France and 7 more countries
University of Sydney · Sites in Germany, Australia, Canada and 3 more countries
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 169 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
109 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 16 · Phase 3 26 · Phase 4 9
First in 1994; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 77 is below the median of 120 across 443 observational studies indexed under Kidney Failure, Chronic.
Median enrollment 81 across the 86 interventional studies, 119 across the 23 observational. Of the 85 that completed or were terminated, 26 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
65 of 109 have an industry lead sponsor. The 10 most frequent:
University Hospital Erlangen is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
University Hospital Erlangen has 1 study filed under Kidney Failure, Chronic — fewer than ten, so there is no comparison to draw.
4 of the studies in Kidney Failure, Chronic with a site in Germany that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03994471Phase 3Iperboreal Pharma SrlEfficacy and Safety of XyloCore Peritoneal Dialysis Solution. | 2026-12-31 |
| NCT05970172Phase 3Astellas Pharma Global Development, Inc.A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease | 2027-10-30 |
| NCT02823821University of SydneyRandomised Evaluation of Sodium Dialysate Levels on Vascular Events | 2026-12 |
| NCT05846581W.L.Gore & AssociatesRegistry of GORE® ACUSEAL Vascular Graft in Dialysis Access | 2027-10-27 |
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Among the 109 studies in Kidney Failure, Chronic with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Treatment of patients with end-stage renal disease and critical limb ischemia still poses challenges to vascular medicine due to limited survival, comorbidities and infrapopliteal involvement of arteriosclerosis in these patients.
Most optimal vascular therapy mode has not been finally decided in these patients.
Therefore retrospective analysis of patients receiving open surgical and endovascular revascularisation was performed.
Query of internal clinical database for identification of patients (2009-2017)with end-stage renal disease and critical limb ischemia, receiving either open surgical (Group I "OR") or endovascular revascularisation (Group II "EVT").
Furthermore, retrospective comparison as to morphological criteria (lesion length, peripheral run-off, plantar arch) and comorbidities.
Prospective follow-up of identified patients by means of telephone contacts and/or clinical examination of evaluation of Long-term outcome measures (Overall survival, Amputation-free survival, wound healing)
study Population comprises of all dialysis patients treated for critical limb ischemia by means of surgical or endiovascular Intervention at University Hospital Erlangen between 2009 and 2017
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Exclusion Criteria:
patients treated with open revascularization
Procedure: open revascularization
patients treated with endovascular revascularization
Procedure: endovascular revascularization
surgical revascularization (i.e. Bypass surgery)
endovascular revascularization (stent, ballon angioplasty)
Amputation free survival
Evaluation of limb salvage and survival as Composite endpoint
Time frame: 24 months
Overall survival
Evaluation of Overall survival rate
Time frame: 24 months
Major Amputation
Evaluation of Major Amputation rate
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Sep 2017, 2 months.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University Hospital Erlangen