An observational study in Congenital Solitary Kidney, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Status unknown at 1 site in Italy. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2013-04-15.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
Among 192 studies in Hypertension with a site in Italy — 33 open to participants now, 38 under way, 7 of them phase 3. Hypertension · Italy.
Among the 192 studies in Hypertension with a site in Italy, this one is the 44th largest by planned enrollment of the 56 observational ones, is one of 6 that started in 2010, is one of 57 observational ones, and was the 78th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 120 is below the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →33 of the 192 studies in Hypertension with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: Up to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →192 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 6 started in 2010.
Median enrollment 240 across the 134 interventional studies, 283 across the 56 observational. Of the 116 that completed or were terminated, 44 (38%) have results posted.
82 of 192 have an industry lead sponsor. The 10 most frequent:
IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
IRCCS Azienda Ospedaliero-Universitaria di Bologna has 3 studies filed under Hypertension — fewer than ten, so there is no comparison to draw.
11 of the studies in Hypertension with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT07206875IRCCS San RaffaeleObservational Study for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine Disorders | 2026-11 |
| NCT07494279Liaquat University of Medical & Health SciencesEfficacy of Nigella Sativa (Nisatol®) in Women With Borderline Blood Pressure Values or a Non-Dipper Blood Pressure Phenotype | 2026-11-30 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
| NCT06059638Orchestra BioMed, IncBradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT | 2026-12 |
Among the 192 studies in Hypertension with a site in Italy, from their registry updates:
Congenital solitary kidney (CSK) is a disorder caused by an abnormal development of one of the two kidneys. The reported incidence ranges between 1:450-3200. It is debated whether CSK is a benign condition or not. A variable risk of developing proteinuria (11-27%), hypertension (0-60%) and chronic kidney damage (3.5-30%) is described. This knowledge derives mainly from retrospective studies performed in tertiary medical centers which is difficult to compare for the following reasons: the number of individuals evaluated, the length of follow-up and the outcome studied.
The aim of this longitudinal study is to assess, in a cohort of children with congenital solitary kidney, during a 10 year follow-up period: 1) the rates of developing proteinuria, hypertension and chronic kidney disease and the corresponding potential prognostic factors. 2) the role of new biomarkers of glomerular (Cystatin C) or tubular damage (NGAL, NAG, B2-microglobulin) in predicting the appearance of chronic kidney damage.
Congenital Solitary kidney (CSK) is a disorder caused by the abnormal development of one of the two kidneys. This abnormality can be either anatomical, caused by unilateral renal agenesis (RAG), or functional, caused by extreme forms of dysplasia (renal aplasia-RAP and multicystic dysplastic kidney disease-MCKD). The reported incidence is between 1:450-3200 with no difference between the two sexes. CSK is a subgroup of a large family of Congenital Anomalies of the Kidney and Urinary Tract (CAKUT), which are caused by abnormal embryologic development. Physiologically, the development of the kidney begins during the 3rd week of gestation and proceeds through a series of phases: the pronephros, mesonephros, and metanephros. While abnormalities of the early pronephros-mesonephros phases lead to renal agenesis, an aberrant metanephros phase can cause a more wide spectrum of CAKUT. CAKUT are the leading cause of chronic (50%) and end stage (40%) kidney disease in children. While this risk is well known for some phenotypes (e.g. bilateral renal hypodysplasia and posterior urethral valves), whether CSK is a benign condition or not, has been the subject of recent debate. The knowledge of the natural history of CSK originates mainly from retrospective studies often performed in tertiary medical centers which are difficult to compare for several reasons: the number of individuals studied varied considerably as did the underlying CSK disorders (RAG, MCKD or RAP), the length of follow-up and the type of outcomes considered. These studies show an extremely variable risk of developing proteinuria (11-27%), hypertension (0-60%), and chronic kidneys disease (3.5-30%). So there are many difficulties which prevent us from understanding: a) which phenotype (RAG, MCKD or RAP) or risk factors could influence the progression to an adverse outcome; b) whether or not the compensatory hypertrophy and resulting hyperfiltration acts as a protective mechanism. Recently, Sanna-Cherchi et al. retrospectively analyzed the long-term renal outcome of over 300 children with CAKUTs. With simple selection criteria, dialysis-free survival from birth was modelled to account for concomitant vesicoureteral reflux, age at diagnosis, hypertension, proteinuria, and serum creatinine concentration. Surprisingly the analysis revealed that patients with solitary kidney have a probability of nearly 50 % of requiring dialysis by 30 years of age. This clinical outcome raises the possibility that subclinical defects could be present in the congenital solitary kidney which may account for a poorer prognosis. This hypothesis is also supported by the fact that the long-term prognosis in individuals with acquired single kidney (e.g. transplant donors or subject nephrectomized for Wilm's tumor) appears to be excellent. This reported high risk of poor outcome in CSK patients has highlighted the need for understanding: 1) the rate and the factors determining progression to end-stage renal disease; 2) the development of biomarkers to improve early detection. Usually, children with CSK are not always subjected to long term follow-up and when they are, monitoring involves plasma creatinine concentration , proteinuria and ultrasonography. Because most cases of endstage renal disease in children result from tubulointerstitial rather than glomerular disorders, serum creatinine and urine protein determinations are relatively insensitive. New biomarkers are now available that can facilitate the early identification of changes in renal function before they become irreversible. These biomarkers of glomerular (serum Cystatin C) or tubular damage (urine alfa-1 and beta-2 microglobulin, urine lysozyme, serum and urine neutrophil gelatinase associated lipocalin (NGAL), urine Na+/H+ exchanger (NHE3), urine Kidney injury molecule 1 (KIM1), urine N-acetyl-beta-D-glucosaminidase (NAG), already validated for various kidney diseases (acute renal failure, nephrotic syndrome, etc), could be useful in the early identification of damage in CSK patients.
The aim of this longitudinal study is to assess, in a cohort of children with CSK, during a 10-year follow-up period:
Study population:
Study group: male and female children, aged 0-18 years, diagnosed with CSK, documented by renal ultrasonography and confirmed by dimercaptosuccinic acid (DMSA) Scan. Written informed consent will be obtained. Children with chronic renal failure, posterior urethral valves, diabetes, heart and/or vascular diseases and autoimmune diseases will be excluded. Subjects will be enrolled at the Paediatric Nephrology Department of the Sant'Orsola Malpighi Hospital, Bologna, as in and/or outpatients from the 1st April 2010 to 30th April 2013; the follow-up of each subject will continue for 10 years.
At the baseline all children will be assess by:
Patient follow-up and monitoring:
If age ≤ 2 years: at 2 , 5 and 10 ten years; If age > 2 years: at entry and then every five years; 5. Ambulatory blood pressure measurement: If age ≤ 7 years: at 7 years, 10 years and at the end of follow-up; If age > 7 years at entry and then every five years.
The following epidemiological, clinical and laboratory data will be collected:
Epidemiological data:
Clinical data:
Laboratory data:
Instrumental data:
Children aged 0 - 18 years, diagnosed with a CSK (defined as a single functioning kidney documented and confirmed by DMSA Scan.).
Subjects will be enrolled from 1st June 2010 to 30th Jume 2013 at the Paediatric Nephrology Department of the Sant'Orsola Malpighi Hospital, the follow-up of each subject will continue for 10 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children with chronic renal failure, posterior urethral valves, diabetes, heart and/or vascular diseases and diseases will be excluded. Subjects will be enrolled at the
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic kidney disease
Chronic kidney disease defined by National Kidney Foundation's Kidney Disease Outcomes Quality Initiative clinical practice guidelines for chronic kidney disease in children and adolescents with a glomerular filtration rate less than 89 ml/min/1.73 m2.
Time frame: 10 years
Proteinuria
Proteinuria defined by the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative as a urine protein/urine creatinine ratio of more than 0.5 in children younger six months and of more than 0.2 in older children.
Time frame: 10 years
Hypertension
Hypertension defined by the National High Blood Pressure Education Program Working Group as a blood pressure ≥ 95th percentile
Time frame: 10 years
The record gives a start of Jun 2010, a primary completion of Jun 2013 and a completion of Jun 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
IRCCS Azienda Ospedaliero-Universitaria di Bologna →