Clinical trials: sponsored by Mario Negri Institute for Pharmacological Research
Autosomal Dominant Polycystic Kidney
Outcome of ADPKD With Octreotide LAR
In this observational, retrospective study we will primarily aim at evaluating the independent role of baseline clinical and laboratory parameters, including TKV, in the prediction of long term chronic GFR decline and other…
- Trial name
- ADPKD648 (NCT06193616)
- Testing
- Octreotide
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Renal Diseases, Cerebral Disorder
New Advanced Vascular Imaging Ultrasound Protocols
This is a single-center observational study aimed at setting up and testing new ultrasound vascular imaging protocols, conducted exclusively for research purposes. The study will perform US examinations in 60 subjects.
- Trial name
- RESONA-SETTING (NCT06841887)
- Testing
- US acquisitions
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Nephrotic Syndrome
Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome
This retrospective study is aimed at evaluating the levels of circulating anti-nephrin autoantibodies in patients with INS, including those with MCD/FSGS and in patients who have experienced relapse of FSGS post-transplant…
- Trial name
- BLINDER (NCT06334692)
- Testing
- In-house ELISA, and ELISA kits from "DBA Italy" (Abbexa).
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Kidney Replacement
1 vs 7 RATG Infusions in Renal Transplantation
This trial is to compare the risk/benefit profile over six-month follow-up of two induction immunosuppressive regimens based on one or seven low-dose perioperative RATG infusions on top of the same induction therapy with…
- Trial name
- ONSET (NCT06374095)
- Testing
- RATG, Basiliximab
- Where
- Italy
- Volunteers
- 75 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Hyperkalaemia, Chronic Kidney Disease Stage 3 and 4
Patiromer and Diet/hrQoL in Chronic Dialysis
This is a phase III, prospective, randomized, double-blind, placebo-controlled, single-center, pilot trial, aimed at assessing whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or…
- Conditions
- Hyperkalaemia, Chronic Kidney Disease Stage 3 and 4, Dietary Intervention
- Trial name
- PRINCE (NCT06858280)
- Testing
- Patiromer 8400 MG [Veltassa]
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Kidney Diseases, Brain Diseases
Medical Images Collection Research
This is a not-for-profit project for the collection, archiving and reuse of magnetic resonance imaging, computed tomography and ultrasound images, and related demographic and clinical data, for research purposes only.
- Trial name
- MEDICALBUM (NCT06354829)
- Testing
- Medical imaging procedures
- Where
- Italy
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Nephrotic Syndrome
Comparing the Performance of Serum Creatinine and Cystatin C-based GFR Estimations in Predicting Directly Measured GFR in Patients With or Without Nephrotic Syndrome
This observational study relates to subjects with primary membranous nephropathy enrolled in the ongoing PEPTIDE, MONET, and ORION clinical trials performed and coordinated by IRFMN (NCT04095156, NCT04893096, and NCT05050214…
- Trial name
- Cy-STEM (NCT06797609)
- Testing
- Sample analyses
- Where
- 2 sites in Italy
- Volunteers
- 50 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
End Stage Renal Disease
Blood Flow Conditions and Sounds in AVFs
This is a prospective non-pharmacological interventional study aimed at investigating the relationship between the blood flow condition and the arteriovenous fistula (AVF) sound, with the ultimate aim of predicting the AVF…
- Trial name
- APOLLO (NCT06411353)
- Testing
- MRI acquisition, US examination
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Multiparametric MRI
Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners
This is an interventional, multicenter, prospective study involving healthy volunteers, to primarily assess the reproducibility of multiparametric renal MRI on 1.5T scanners.
- Trial name
- NCT06884410
- Testing
- MRI
- Where
- 4 sites in Denmark, Germany and 2 more
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Simulated and Synthetic Health Data: Improving Clinical Research on Rare Diseases. A Real-World Data Simulation of Autosomal Dominant Polycystic Kidney Disease (ADPKD) Trials. A Retrospective, Observational Study
This is a no-profit, retrospective observational study involving real-world data (RWD), retrieved from ADPKD-related electronic health records stored at Mario Negri Institute IRCCS.
- Trial name
- SAILING-ADPKD (NCT07016282)
- Where
- 2 sites in Italy, Sweden
- Volunteers
- 100 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Epilepsies, Partial
Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)
There are no guidelines on the first maintenance daily dose of antiepileptic drugs (AEDs) in newly diagnosed, previously untreated epilepsy.
- Trial name
- STANDLOW (NCT03689114)
- Testing
- Low dose carbamazepine, Standard dose carbamazepine, Low dose levetiracetam
- Where
- Italy
- Volunteers
- 58 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Endometrial Cancer
Atezolizumab Trial in Endometrial Cancer - AtTEnd
Atezolizumab is an engineered humanised monoclonal immunoglobulin G1 antibody that binds selectively to PD-L1 and prevents its interaction with PD-1 and B7-1.
- Trial name
- AtTEnd (NCT03603184)
- Testing
- Atezolizumab, Paclitaxel, Carboplatin
- Where
- 93 sites in Australia, Austria and 9 more
- Volunteers
- 549 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Epidemiology of Cardiovascular Risk
Selection of People at Low Cardiovascular Risk: Development of an Inexpensive Pre-screening Algorithm Using Only Non-laboratory Measures. The SKIM Risk Study.
Early identification of individuals at high risk remains the cornerstone of primary cardiovascular prevention (CV). However, cardiovascular screening including people at low CV diseases (CVD) risk are too costly, time consuming…
- Trial name
- SKIM (NCT03962309)
- Testing
- Health self-assessment questionnaire
- Where
- 3 sites in Italy
- Volunteers
- 2,699 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Chronic Kidney Diseases, Healthy
Multiparametric MRI in Healthy Volunteers and CKD Patients
Chronic kidney disease (CKD) is a global health concern because more than 10% of the world's population have it, its prevalence is increasing, and CKD is an important contributor to morbidity and mortality for this population.
- Trial name
- RESPECT (NCT05229263)
- Testing
- Non- contrast Enhanced Multiparametric Renal Magnetic Resonance
- Where
- 4 sites in Denmark, Germany and 2 more
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Ovarian Cancer, Fallopian Tube Cancer
Newton Study (NEW Dosing MainTenance Therapy Ovarian CaNcer)
This study evaluates whether the adoption of the RADAR dosing strategy could further reduce treatment related toxicities improving the safety profile of niraparib.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Trial name
- Newton (NCT03891576)
- Testing
- Niraparib
- Where
- 12 sites in Germany, Italy
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Ovarian Neoplasms
Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib
This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian…
- Trial name
- BAROCCO (NCT03314740)
- Testing
- Paclitaxel, Cediranib, Olaparib
- Where
- 6 sites in Italy
- Volunteers
- 123 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Familial Fatal Insomnia
Familiar Fatal Insomnia: Preventive Treatment With Doxycycline in Subject With Disease Risk
The neurodegenerative disorders is a class o pathologies including very common diseases as Alzheimer or Parkinson or very rare as fatal familial insomnia (FFI), the progression of the disease with no therapeutic remedy is the…
- Trial name
- FFI (NCT04846335)
- Testing
- Doxycycline Hcl
- Volunteers
- 29 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Peripheral Artery Disease
Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with…
- Trial name
- PAD&CAD (NCT03921905)
- Testing
- ABI measurement
- Where
- 4 sites in Italy
- Volunteers
- 713 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Diabetic Kidney Disease
NEPHSTROM for Diabetic Kidney Disease
The study will investigate, primarily, the safety, feasibility and tolerability and, secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects…
- Trial name
- NEPHSTROM (NCT02585622)
- Testing
- Mesenchymal Stromal Cells
- Where
- 4 sites in Ireland, Italy and 1 more
- Volunteers
- 29 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Nephrotic Syndrome
B Cells in Idiopathic Nephrotic Syndrome
The main aim of the present study is to determine whether reconstitution of different B-cell subpopulations can predict relapse after treatment with B-cell depleting antibodies in adult with NS, and whether specific B- or T-cell…
- Trial name
- BLADE (NCT05712369)
- Testing
- Blood sampling
- Where
- Italy
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research