Clinical Trials

Salford Royal offer a number of clinical trials for our patients to participate in.

Here is a list of our current trials:

  • UK Calciphylaxis Study
  • CRISIS Chronic Renal Insufficiency Standards Implementation Study
  • CRISIS-HD Chronic Renal Insufficiency Standards Implementation Study – Haemodialysis
  • DOPPS 5 Dialysis Outcomes and Practice Patterns Study Program
  • EQUAL-study, a European QUALity Study on treatment in advanced chronic kidney disease
  • BiCARB Study
  • FEPOD Frail Elderly Patient Outcomes on Dialysis
  • MANVAS Manchester Vascular Access Study
  • PD-CRAFT Peritoneal Dialysis Competitive Risk Analysis For Long-Term Outcomes www.keele.ac.uk/pd-craft/
  • SPIRiT Serum Phosphate Intervention in Renal Replacement Therapy
  • AUTO_MN Autoimmunity in Membranous Nephropathy
UK Calciphylaxis Study

UK Calciphylaxis Study

UK Calciphylaxis Study, Coordinating Centre, Salford Royal NHS Foundation Trust. Part of ICCN.

Salford Royal NHS Foundation Trust

Clinical Trials

Royal Manchester Children's Hospital offer a number of clinical trials for our patients to participate in.

Here is a list of our current trials:

  • PREDnisolone in NephrOtic Syndrome: The PREDNOS study
  • PREDNOS 2
  • Imaging bioMarker exPloratory (IMP) study for children with SSNS
  • Investigation of the Oxford IgA scoring system in childhood Henoch-Schonlein Pupura Nephritis
  • Safety and Efficacy of Paricalcitol in Paediatric Stage 3/4 CKD (Abbvie)
  • National Study of Membranoproliferative Glomerulonephritis (RADAR)
  • Ferumoxytol for Iron Deficiency Anaemia in patients with CKD (AMAG)
  • Extension Study of Ferumoxytol for Iron Deficiency Anaemia in CKD (AMAG)
  • Prograf to Advagraf conversion study in children (Astellas 1206)
  • Studies of Modigraf in young de novo paediatric transplant recipients (OPTION and PROGRESSION – Astellas)
  • Randomised controlled trial comparing Advagraf and Prograf in de novo paediatric kidney recipients, with long term follow up (Astellas 1207 study)
  • Level of BP control and target organ damage in children with CKD (HotKid study)
  • Genetics of steroid sensitive nephrotic syndrome
  • National Study of Steroid Resistant Nephrotic Syndrome in Childhood (RADAR)

PREDnisolone in NephrOtic Syndrome (PREDNOS)

PREDNOS is a national multicentre randomised double blind trial to compare an extended (sixteen week) tapering prednisolone (steroid) regimen with the standard eight week regimen as originally proposed by the International Study of Kidney Disease in Children (ISKDC) for the treatment of the initial episode of childhood nephrotic syndrome.

The study aims to recruit a total of 224 children (112 in each arm) over two years and patients will be followed up for at least 24 months. Here at RMCH, we have exceeded our recruitment target of 10 and have enrolled an impressive 14 patients into the trial so far.

The trial is co-sponsored by the University of Birmingham and Central Manchester University Hospitals NHS Foundation Trust. Funding has been awarded by the National Institute for Health Research Health Technology Assessment programme (NIHR HTA)

Please go to the PREDNOS website, click here for more details about the trial.


PREDNOS 2

PREDNOS 2 is a national multicentre double blind randomised controlled trial to evaluate the effectiveness of a six day course of daily prednisoline therapy at the time of URTI in reducing the development of subsequent nephrotic syndrome relapse in children with relapsing steroid sensitive nephrotic syndrome (SSNS).

The study aims to recruit 300 patients (150 in each arm) over a two year period and patients will be followed up for 12 months. Currently, over 120 UK sites are participating in the study. The first patient recruited into the study was here at RMCH and we only have 2 more patients to enrol to reach our recruitment target.

The trial is co-sponsored by Central Manchester University Hospitals NHS Foundation Trust and University of Birmingham and funded by the National Institute for Health Research Health Technology Assessment programme (NIHR HTA).

Please go to the PREDNOS 2 website, click here for more details about the trial.


Imaging BioMarker ExPloration for Prednisolone Induced Brain Changes in Children with Idiopathic Steroid Sensitive Nephrotic Syndrome (IMP) Study

This is a pilot observational study to identify and evaluate the magnitude and extent of any possible anatomical and physiological MRI based imaging changes seen in children with Idiopathic Steroid Sensitive Nephrotic Syndrome following high-dose corticosteroid therapy. We will be using the new state of the art 3T scanner, housed at the Wellcome Trust Clinical Research Facility, and we will also be administering behavioural questionnaires to children and their parents and performing biochemistry testing on blood and urine samples. The ability to generate imaging biomarkers related to treatment change in this patient cohort may inform on lasting damage to the brain and potentially identify patients with cumulative changes which would preclude further treatment or specify lower dose steroid regimens. We are aiming to recruit 15 children (6-13 years) for this study.

Diagnosing acute kidney injury (DAKI)

Acute kidney injury (AKI) is common in children admitted to intensive care, however the existing measure of renal function (serum creatinine) is limited. The DAKI study was a feasibility project to investigate the utility of new AKI biomarkers (KIM-1, NGAL and cystatin-C) and it recruited 49 children (2011-2012). The data are now being prepared for publication. This study has been followed by 2 additional studies to assess firstly the use of new AKI biomarkers for predicting renal recovery in children requiring renal replacement therapy and secondly the added value of renal perfusion sensing (with near infrared spectroscopy) for managing AKI. Both of these studies are currently recruiting on the intensive care unit at the Royal Manchester Children’s hospital.


Royal Manchester Children's Hospital Royal Manchester Children's Hospital

Clinical Trials

Manchester Royal offer a number of clinical trials for our patients to participate in.

Here is a list of our current trials:

  • RituxiCAN-C4 – RCT of anti-CD20 in patients with C4d+/- chronic allograft nephropathy
  • TransCal – Prospective Analysis of Calcium Metabolism in Transplant patients
  • PD Craft – A Study of Clinical and Genetic Risk Factors for Encapsulating Peritoneal Sclerosis www.keele.ac.uk/pd-craft/
  • BLISS-LN – Belimumab in Acute Lupus Nephritis
  • RENEPHRA – Investigating methods of transdermal fluid extraction
  • DAARD – Investigating Depression and Anxiety in Advanced Renal Disease
  • DAKI – Diagnosing AKI in Paediatric Intensive Care
  • SPIRIT – Serum Phosphate Intervention in Renal Replacement Therapy
  • UK Calciphylaxis Study www.calciphylaxis.org.uk
  • EPIVAS
  • UKVAS – Development of a Pan UK Vasculitis Cohort to Analyse Variations in Disease Susceptibility and Outcomes
  • PEXIVAS – Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis
  • AUTO-MN – Autoimmunity in Membranous Nephropathy. National lead site.
  • BEL114672 – A 2 year study of efficacy and safety of belimumab versus placebo in subjects and a mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy
  • MANVAS – A prospective observational study to understand natural history and biology of AV access maturation and identify risk factors for AVF failure
  • FEPOD – Frail and Elderly Patient Outcomes on Dialysis (Part 2)
  • Vital Access (SAVE-2) – A prospective, multi-centre, observational pilot study to investigate the safety and efficacy of the Venous Window Needle Guide (VWNG)
  • Perfusion Study (CAD-MP)
  • Increasing Organ Donation in the North West South Asian Community through Strategic Intervention
  • CEUS in Kidney and Pancreas Transplantation
  • ReMIND – RCT of Rituximab in induction therapy for living donor renal transplantation
  • ReMIND – RCT of Rituximab in induction therapy for living donor renal transplantation
  • BASIC-HHD study – Barriers to Successful Implementation of care in home haemodialysis – NIHR Portfolio ID 12346
Royal Manchester Infirmary Royal Manchester Infirmary Royal Manchester Infirmary