Safety Outcomes Post Kidney Biopsy - Randomized Clinical Evaluation of Efficacy of Desmopressin

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

It is a randomized, multicenter, double-blind, placebo controlled, interventional clinical trial that will be conducted in Poland, in about 6 Hospital Nephrology Departments to evaluate the safety and effectiveness of desmopressin on the prevention of bleeding after percutaneous needle kidney biopsy in patients with rare and ultrarare glomerulonephritis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• ≥ 18 years old

• Ability to provide Informed Consent

• Qualification by nephrologist to kidney biopsy in accordance to current standards

• Initial haemoglobin concentration \> 8g/dl and PLT count \>100 x103/μL

• Normal range of APTT and INR

• Blood pressure control defined as SBP\<160 mmHg

• Permitted antiplatelet/antithrombotic drugs: acetylsalicylic acid and heparin

• No inflammation at the point of biopsy needle insertion

Locations
Other Locations
Poland
II Department of Nephrology and Hypertension
RECRUITING
Bialystok
Contact Information
Primary
Alicja Rydzewska-Rosołowska, Assoc.Prof.
alicja.rydzewska-rosolowska@umb.edu.pl
+48 604 330 187
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 424
Treatments
Experimental: Experimental
0,3ug/kg in 100ml 0,9% NaCl managed as intravenous infusion;
Placebo_comparator: Placebo comparator
0,9% NaCl managed as intravenous infusion;
Related Therapeutic Areas
Sponsors
Leads: Medical University of Bialystok

This content was sourced from clinicaltrials.gov