Evaluation of Renastep
Condition: Chronic Kidney Diseases; Renal Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      Evaluation of Renastep is a 28-day long, prospective nutritional study that will recruit 15
      patients aged between 3 and 18 years of age with Chronic Kidney Disease. Participants will
      incorporate Renastep into their renal specific diet, during which time they will record
      gastrointestinal symptoms, adherence to recommended intakes and thoughts on its palatability.
      A Baseline CRF completed by the Investigator at the start of the trial will record
      demographic information, GI history and the most recent renal bio-marker results. Bio-marker
      results recorded as part of routine care over the course of the study will be captured in the
      End of Study CRF.

      The study is designed to generate acceptability data that will be used to support an
      application to the Advisory Committee on Borderline Substances for Renastep to be
      reimbursable on prescription within the NHS.
    

Detailed description: 
      Renastep is designed for use in the dietary management of kidney disease between 3 and 18
      years of age. It is a high-energy liquid feed containing protein, carbohydrate, fat,
      vitamins, minerals, trace elements and DHA. It contains low levels of potassium, phosphorus,
      calcium, chloride and vitamin A compared with a standard paediatric enteral feed.

      Vitaflo (International) Ltd has developed Renastep following a request from the Paediatric
      Renal Interest Nutrition Group (PRING). They requested a low potassium and phosphate, high
      energy liquid feed for the dietary management of children with kidney disease that can be
      used as a sip feed or as a part of a modular tube feed.

      There is currently no product designed specifically for use in this age group. Current
      dietetic practice involves either prescribing a powdered infant formula, in variable
      concentrations, or manipulating an adult renal sip feed to construct a modular feed, meeting
      the particular individual requirements of a paediatric patient with chronic kidney disease.
      This can be time consuming, complicated, can frequently involve preparation error leading to
      over or underconcentration of key nutrients, and increases the risk of microbial
      contamination. As Renastep is a ready to use product designed specifically for children with
      kidney disease, it can be expected that it will be more easily incorporated into the dietary
      management of the patient than the current options available. This has also been requested by
      the children and their families. Renastep could replace unsafe current practices that are the
      only option available to clinicians.

      In order for Renastep to be prescribed within the NHS, it must first be subject to an
      application to the Advisory Committee on Borderline Substances (ACBS). The ACBS require data
      on the product's acceptability, in terms of gastrointestinal tolerance, palatability and
      participants' adherence to recommended intakes. The ACBS require such acceptability studies
      to be conducted in at least 15 patients for whom the product is designed. This stipulation is
      the reason for conducting the trial within patients aged 3 - 18 years of age with Chronic
      Kidney Disease.

      The study will last for 28 days. Participants will self-report study data in Daily Diary
      forms that include 7 days of gastrointestinal data, daily records of how much of the product
      has been taken compared to the amount prescribed and a final evaluation of the product's
      palatability. The investigator will complete a Baseline CRF at the first visit to record
      demographic information, GI history and the most recent urea, phosphorus and potassium
      results. This will be supplemented by an End of Study CRF which will record urea, phosphorus
      and potassium results recorded during the trial period as part of usual clinical care.
      Information relating to gastrointestinal tolerance of Renastep over the 28-day study period
      will also be recorded by the Investigator in the End of Study CRF.

      All study data will be anonymised and reviewed by the local investigator prior to it being
      forwarded to the sponsor, Vitaflo (International) Ltd.
    

Intervention name(s): Renastep
Intervention type(s): Dietary Supplement
Intervention description(s): Renastep is a ready-to-use, high energy, low volume liquid renal specific feed that can be administered enterally via tube or oral consumption.
Intervention model: Single Group Assignment
Intervention model description: Open label prospective acceptability study.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Acceptability; Renal; CKD; Kidney; Vitaflo; High energy, low volume; Low potassium; Low phosphorus; Low vitamin A