Rare and ultra-rare glomerulonephritis MedDRA version: 20.1 Level: PT Classification code 10018364 Term: Glomerulonephritis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Minirin (4 mcg/ml)
Pharmaceutical Form: Infusion
INN or Proposed INN: DESMOPRESSIN
CAS Number: 16679-58-6
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concen
Sponsors
Medical University of Bialystok
Eligibility
Sex/Gender
All
Inclusion criteria
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=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1. Initial sodium concentration 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of safety and effectiveness desmopressin used before percutaneous needle kidney biopsy for bleeding prevention, in the population of patients with rare and ultra-rare glomerulonephritis.;Secondary Objective: Assessment of safety and effectiveness desmopressin used before percutaneous needle kidney biopsy for hospitalization time and AESI frequency.;Primary end point(s): Efficacy primary outcome: 1.Number of major and minor bleeding events in 24 h after the procedure which is defined as: •minor bleeding events: macroscopic haematuria; clinically silent hematoma in ultrasound in 24h after biopsy, decrease in haemoglobin concentration >20% in regards to initial values. •Major bleeding events: transfusion of red cells concentrate, embolisation, nephrectomy, bleeding related directly and indirectly death. Safety primary outcome 1.Hyponatremia 24 and 48 h after biopsy ;Timepoint(s) of evaluation of this end point: Efficacy primary outcome: 24 hours after biopsy procedure Safety prrimary outcome: 24 and 48 after biopsy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy secondary outcome : 1. Hospitalization time from kidney biopsy till discharge 2. Cost-effectiveness analysis of desmopressin use Safety secondary outcome Frequency of AEs of special interest: • Tachycardia HR>100 BPM • Hypotension defined as SBP <90 mmHg or MAP <65 mgHg or a systolic blood pressure decrease of 40 mmHg. • Any thrombotic events ;Timepoint(s) of evaluation of this end point: Hospitalization time from kidney biopsy till discharge. | — |
Countries
Poland
Contacts
Public ContactNational Coordinator
Medical University of Bialystok
Outcome results
None listed