Efficacy of Desmopressin in safaty outcomes post kindey biopsy

Phase 1

Conditions: Rare and ultra-rare glomerulonephritis
MedDRA version: 20.1Level: PTClassification code 10018364Term: GlomerulonephritisSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Not possible to specify

Registration Number: EUCTR2021-006647-99-PL

Lead Sponsor: Medical University of Bialystok

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 424

Inclusion Criteria

1.= 18 years old
2.Ability to provide Informed Consent
3.Qualification by nephrologist to kidney biopsy in accordance to current standards
4.Initial haemoglobin concentration > 8g/dl and PLT count >100 x103/µL
5.Normal range of APTT and INR
6.Blood pressure control defined as SBP<160 mmHg
7.Permitted antiplatelet/antithrombotic drugs: acetylsalicylic acid and heparin
8.No inflammation at the point of biopsy needle insertion

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

1. Initial sodium concentration <130mmol/l
2.Pregnancy and breastfeeding
3.Anaphylactic shock after desmopressin administration (medical history)
4.Necessity of administration other anti-platelet / anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin
5.Decompensated Heart failure
7.Von Willebrand disease (VWD) type II B
8.As per Investigator opinion a medical situation which may lead to increased intracranial pressure (ICP)
10.Hydronephrosis of the biopsied kidney
11.Usage of any prohibited drug before screening :
•ASA in dosage > 75mg per day
•Vitamin K antagonist (VKA)
•Direct oral anticoagulants (DOAC)
•Low-molecular-weight heparin (LMWH)
•Unfractionated heparin (UFH)
Except situation when dosage of listed above drugs will be adjusted in accordance to protocol