About this guideline

NICE clinical guidelines are recommendations about the treatment and care of people with specific diseases and conditions.

NICE guidelines are developed in accordance with a scope that defines what the guideline will and will not cover.

This guideline was developed by the National Clinical Guideline Centre, which is based at the Royal College of Physicians. The Centre worked with a Guideline Development Group, comprising healthcare professionals (including consultants, GPs and nurses), patients and carers, and technical staff, which reviewed the evidence and drafted the recommendations. The recommendations were finalised after public consultation.

The methods and processes for developing NICE clinical guidelines are described in the guidelines manual.

NICE produces guidance, standards and information on commissioning and providing high‑quality healthcare, social care, and public health services. We have agreements to provide certain NICE services to Wales, Scotland and Northern Ireland. Decisions on how NICE guidance and other products apply in those countries are made by ministers in the Welsh government, Scottish government, and Northern Ireland Executive. NICE guidance or other products may include references to organisations or people responsible for commissioning or providing care that may be relevant only to England.

Update information

This guideline updates and replaces NICE guideline CG73 (published September 2008).

Recommendations are marked as [2008], [2008, amended 2014], [2014] or [new 2014]:

  • [2008] indicates that the evidence has not been reviewed since 2008

  • [2008, amended 2014] indicates that the evidence has not been reviewed since 2008, but changes have been made to the recommendation wording that change the meaning

  • [2014] indicates that the evidence has been reviewed but no change has been made to the recommended action

  • [new 2014] indicates that the evidence has been reviewed and the recommendation has been updated or added.

Recommendations from NICE guideline CG73 (2008) that have been amended

Recommendations are labelled [2008, amended 2014] if the evidence has not been reviewed but changes have been made to the recommendation wording that change the meaning.

Recommendation in 2008 guideline

Recommendation in current guideline

Reason for change

To detect and identify proteinuria, use urine ACR in preference, as it has greater sensitivity than PCR for low levels of proteinuria. For quantification and monitoring of proteinuria, PCR can be used as an alternative. ACR is the recommended method for people with diabetes. (1.1.11)

To detect and identify proteinuria, use urine ACR in preference to protein:creatinine ratio (PCR), because it has greater sensitivity than PCR for low levels of proteinuria. For quantification and monitoring of high levels of proteinuria (ACR 70 mg/mmol or more), PCR can be used as an alternative. ACR is the recommended method for people with diabetes. (1.1.18)

'High levels of proteinuria' and the ACR category was added for clarification on quantification and monitoring.

For the initial detection of proteinuria, if the ACR is 30 mg/mmol or more (this is approximately equivalent to PCR 50 mg/mmol or more, or a urinary protein excretion 0.5 g/24 h or more) and less than 70 mg/mmol (approximately equivalent to PCR less than 100 mg/mmol, or urinary protein excretion less than 1 g/24 h) this should be confirmed by a subsequent early morning sample. If the initial ACR is 70 mg/mmol or more, or the PCR 100 mg/mmol or more, a repeat sample need not be tested. (1.1.12)

For the initial detection of proteinuria, if the ACR is between 3 mg/mmol and 70 mg/mmol, this should be confirmed by a subsequent early morning sample. If the initial ACR is 70 mg/mmol or more, a repeat sample need not be tested. (1.1.19)

The criteria for clinically significant proteinuria have been changed from an ACR of 30 mg/mmol or more to 3 mg/mmol or more. Although this question was not directly included in the update, the change came from evidence reviewed for the markers of kidney damage and classification of CKD sections. The GDG agreed that the risk of adverse outcomes is a continuum and starts at an ACR well below 30 mg/mmol.

The equivalences to PCR and urinary protein excretion were removed because the evidence showed that ACR was more accurate.

In people without diabetes consider clinically significant proteinuria to be present when the ACR is 30 mg/mmol or more (this is approximately equivalent to PCR 50 mg/mmol or more, or a urinary protein excretion 0.5 g/24 h or more).(1.1.13)

Regard a confirmed ACR of 3 mg/mmol or more as clinically important proteinuria. (1.1.20)

Replaced with recommendation 1.1.20.

The criteria for clinically significant proteinuria have been changed from an ACR of 30 mg/mmol or more to 3 mg/mmol or more. Although this question was not directly included in the update, the change came from evidence reviewed for the markers of kidney damage and classification of CKD sections. The GDG agreed that the risk of adverse outcomes is a continuum and starts at an ACR well below 30 mg/mmol.

In people with diabetes consider microalbuminuria (ACR more than 2.5 mg/mmol in men and ACR more than 3.5 mg/mmol in women) to be clinically significant. (1.1.14)

Regard a confirmed ACR of 3 mg/mmol or more as clinically important proteinuria. (1.1.20)

Replaced with recommendation 1.1.20

The criteria for clinically significant proteinuria have been changed from an ACR of 30 mg/mmol or more to 3 mg/mmol or more. Although this question was not directly included in the update, the change came from evidence reviewed for the markers of kidney damage and classification of CKD sections. The GDG agreed that the risk of adverse outcomes is a continuum and starts at an ACR well below 30 mg/mmol. There is a general move away from the term 'microalbuminuria' (ACR between 3 and 30 mg/mmol) and the GDG wanted the latest recommendations to reflect this.

Additionally it was no longer felt appropriate to have different criteria for gender. The GDG was not aware of any evidence on which the gender differences were based.

All people with diabetes, and people without diabetes with a GFR less than 60 ml/min/1.73 m2, should have their urinary albumin/protein excretion quantified. The first abnormal result should be confirmed on an early morning sample (if not previously obtained).(1.1.15)

Quantify urinary albumin or urinary protein loss as in recommendation 1.1.18 for:

  • people with diabetes

  • people without diabetes with a GFR less than 60 ml/min/1.73 m2 (1.1.21)

The second part of the original recommendation (regarding confirming on an early morning sample) was removed because modified criteria are provided in recommendation 1.1.19.

Other changes for clarification only – see clarification table.

Monitor GFR in people prescribed drugs known to be nephrotoxic such as calcineurin inhibitors and lithium. Check GFR at least annually in people receiving long-term systemic non-steroidal anti-inflammatory drug (NSAID) treatment. (1.1.21)

Monitor GFR at least annually in people prescribed drugs known to be nephrotoxic, such as calcineurin inhibitors (for example cyclosporin or tacrolimus), lithium and non-steroidal anti-inflammatory drugs (NSAIDs). [2008, amended 2014]

The frequency of monitoring was added for nephrotoxic drugs based on the British National Formulary, which no longer indicates a difference in monitoring needs between NSAIDs and other nephrotoxic drugs. Annual monitoring was agreed by the GDG as appropriate for all of these drugs.

Examples of calcineurin inhibitors were added for clarification.

In the absence of the above risk factors, do not use age, gender or ethnicity as risk markers to test people for CKD. In the absence of metabolic syndrome, diabetes or hypertension, do not use obesity alone as a risk marker to test people for CKD. (1.1.23)

Do not use age, gender or ethnicity as risk markers to test people for CKD. In the absence of metabolic syndrome, diabetes or hypertension, do not use obesity alone as a risk marker to test people for CKD. (1.1.29)

The initial part of the sentence 'In the absence of the above risk factors' was removed.

The 2008 recommendation implied that if risk factors were present then age, gender and ethnicity could be considered as risk factors. The GDG did not find any evidence for this and agreed that rewording the recommendation promotes equality.

For the purposes of this classification define proteinuria as urinary ACR 30 mg/mmol or more, or PCR 50 mg/mmol or more (approximately equivalent to urinary protein excretion 0.5 g/24 hours or more). (1.2.2)

Regard a confirmed ACR of 3 mg/mmol or more as clinically important proteinuria. (1.1.20)

The criteria for clinically significant proteinuria have been changed from an ACR of 30 mg/mmol or more to 3 mg/mmol or more. Although this question was not directly included in the update, the change came from evidence reviewed for the markers of kidney damage and classification of CKD sections. The GDG agreed that the risk of adverse outcomes is a continuum and starts at an ACR well below 30 mg/mmol. The equivalences to PCR and urinary protein excretion were removed because the evidence showed that ACR was more accurate.

Offer a renal ultrasound to all people with CKD who:

  • have progressive CKD (eGFR decline more than 5 ml/min/1.73 m2 within 1 year, or more than 10 ml/min/1.73 m2 within 5 years)

  • have visible or persistent invisible haematuria

  • have symptoms of urinary tract obstruction

  • have a family history of polycystic kidney disease and are aged over 20

  • have stage 4 or 5 CKD

  • are considered by a nephrologist to require a renal biopsy. (1.4.1)

Offer a renal ultrasound scan to all people with CKD who:

  • have accelerated progression of CKD (see recommendation 1.3.3)

  • have visible or persistent invisible haematuria

  • have symptoms of urinary tract obstruction

  • have a family history of polycystic kidney disease and are aged over 20 years

  • have a GFR of less than 30 ml/min/1.73 m2 (GFR category G4 or G5)

  • are considered by a nephrologist to require a renal biopsy. (1.2.5)

The first bullet point was modified to reflect the updated guideline definition of progression based on the evidence reviewed in the frequency of monitoring section (see recommendation 1.3.5).

Take the following steps to identify progressive CKD.

  • Obtain a minimum of three GFR estimations over a period of not less than 90 days.

  • In people with a new finding of reduced eGFR, repeat the eGFR within 2 weeks to exclude causes of acute deterioration of GFR – for example, acute kidney injury or initiation of ACE inhibitor/ARB therapy.

  • Define progression as a decline in eGFR of more than 5 ml/min/1.73 m2 within 1 year, or more than 10 ml/min/1.73 m2 within 5 years.

  • Focus particularly on those in whom a decline of GFR continuing at the observed rate would lead to the need for renal replacement therapy within their lifetime by extrapolating the current rate of decline. (1.5.1)

Take the following steps to identify the rate of progression of CKD:

  • Obtain a minimum of 3 GFR estimations over a period of not less than 90 days.

  • In people with a new finding of reduced GFR, repeat the GFR within 2 weeks to exclude causes of acute deterioration of GFR – for example, acute kidney injury or starting renin–angiotensin system antagonist therapy. (1.3.4)

Be aware that people with CKD are at increased risk of progression to end-stage kidney disease if they have either of the following:

  • a sustained decrease in GFR of 25% or more over 12 months or

  • a sustained decrease in GFR of 15 ml/min/1.73 m2 or more over 12 months. (1.3.5)

When assessing CKD progression, extrapolate the current rate of decline of GFR and take this into account when planning intervention strategies, particularly if it suggests that the person might need renal replacement therapy in their lifetime. (1.3.6)

The first 2 bullet points of the 2008 recommendation were made into a separate recommendation (1.3.4) to emphasise the process to identify progressive CKD.

The third bullet point was updated (1.3.5) based on evidence derived from the frequency of monitoring review, which identified thresholds for progression.

The GDG made a separate recommendation (1.3.6) from the fourth bullet point to give it additional focus, and clarified the wording according to NICE house style.

People with CKD in the following groups should normally be referred for specialist assessment:

  • stage 4 and 5 CKD (with or without diabetes)

  • higher levels of proteinuria (ACR 70 mg/mmol or more, approximately equivalent to PCR 100 mg/mmol or more, or urinary protein excretion 1 g/24 h or more) unless known to be due to diabetes and already appropriately treated

  • proteinuria (ACR 30 mg/mmol or more, approximately equivalent to PCR 50 mg/mmol or more, or urinary protein excretion 0.5 g/24 h or more) together with haematuria

  • rapidly declining eGFR (more than 5 ml/min/1.73 m2 in 1 year, or more than 10 ml/min/1.73 m2 within 5 years)

  • hypertension that remains poorly controlled despite the use of at least four antihypertensive drugs at therapeutic doses (see also 'Hypertension: management of hypertension in adults in primary care' [NICE guideline CG34])

  • people with, or suspected of having, rare or genetic causes of CKD

  • suspected renal artery stenosis. (1.6.1)

People with CKD in the following groups should normally be referred for specialist assessment:

  • GFR less than 30 ml/min/1.73 m2 (GFR category G4 or G5), with or without diabetes

  • ACR 70 mg/mmol or more (ACR category A3), unless known to be caused by diabetes and already appropriately treated

  • ACR 30 mg/mmol or more (ACR category A3), together with haematuria

  • sustained decrease in GFR of 25% or more and a change in GFR category or sustained decrease in GFR of 15 ml/min/1.73 m2 or more within 12 months

  • hypertension that remains poorly controlled despite the use of at least 4 antihypertensive drugs at therapeutic doses (see also Hypertension [NICE guideline CG127])

  • known or suspected of rare or genetic causes of CKD

  • suspected renal artery stenosis. [2008, amended 2014] (1.5.2)

The first bullet point was amended to give GFR values rather than the stages to help clarify the criteria.

In the second bullet point the equivalence to PCR value was removed to ensure consistency of ACR use.

In the fourth bullet point the definition of progression was amended to the 2014 definition (see recommendation 1.3.5).

The fifth bullet point was amended to cross reference the current NICE guideline on hypertension.

Offer dietary advice to people with progressive CKD concerning potassium, phosphate, protein, calorie and salt intake when indicated. (1.7.4)

Offer dietary advice about potassium, phosphate, calorie and salt intake appropriate to the severity of CKD. (1.4.7)

Protein was removed because this was subject to a new evidence review.

The GDG reworded the recommendation to state that advice should be appropriate to the stage of CKD because 'progressive CKD' was considered to be ambiguous as it could refer to anyone with CKD.

ACE inhibitor/ARB therapy should not normally be started if the pretreatment serum potassium concentration is significantly above the normal reference range (typically more than 5.0 mmol/litre). (1.8.11)

Do not routinely offer a renin–angiotensin system antagonist to people with CKD if their pretreatment serum potassium concentration is greater than 5.0 mmol/litre. (1.6.8)

The recommendation was amended for clarity and to reduce the uncertainty implied by changing 'significantly above the normal reference range' to 'greater than 5.0 mmol/litre'.

Strength of recommendations

Some recommendations can be made with more certainty than others. The Guideline Development Group makes a recommendation based on the trade-off between the benefits and harms of an intervention, taking into account the quality of the underpinning evidence. For some interventions, the Guideline Development Group is confident that, given the information it has looked at, most patients would choose the intervention. The wording used in the recommendations in this guideline denotes the certainty with which the recommendation is made (the strength of the recommendation).

For all recommendations, NICE expects that there is discussion with the patient about the risks and benefits of the interventions, and their values and preferences. This discussion aims to help them to reach a fully informed decision (see also patient-centred care).

Interventions that must (or must not) be used

We usually use 'must' or 'must not' only if there is a legal duty to apply the recommendation. Occasionally we use 'must' (or 'must not') if the consequences of not following the recommendation could be extremely serious or potentially life threatening.

Interventions that should (or should not) be used – a 'strong' recommendation

We use 'offer' (and similar words such as 'refer' or 'advise') when we are confident that, for the vast majority of patients, an intervention will do more good than harm, and be cost effective. We use similar forms of words (for example, 'Do not offer…') when we are confident that an intervention will not be of benefit for most patients.

Interventions that could be used

We use 'consider' when we are confident that an intervention will do more good than harm for most patients, and be cost effective, but other options may be similarly cost effective. The choice of intervention, and whether or not to have the intervention at all, is more likely to depend on the patient's values and preferences than for a strong recommendation, and so the healthcare professional should spend more time considering and discussing the options with the patient.

Recommendation wording in guideline updates

NICE began using this approach to denote the strength of recommendations in guidelines that started development after publication of the 2009 version of 'The guidelines manual' (January 2009). This does not apply to any recommendations ending [2008] (see update information for details about how recommendations are labelled). In particular, for recommendations labelled [2008], the word 'consider' may not necessarily be used to denote the strength of the recommendation.

Other versions of this guideline

The full guideline, Chronic kidney disease, contains details of the methods and evidence used to develop the guideline. It is published by the National Clinical Guideline Centre.

The recommendations from this guideline have been incorporated into a NICE pathway.

We have produced information for the public about this guideline.

Implementation

Implementation tools and resources to help you put the guideline into practice are also available.

Your responsibility

This guidance represents the view of NICE, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summaries of product characteristics of any drugs.

Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.

Copyright

© National Institute for Health and Care Excellence 2014. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE.

ISBN: 978-1-4731-0640-6

  • National Institute for Health and Care Excellence (NICE)