Trial Outcomes & Findings for A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease (NCT NCT01688141)

NCT ID: NCT01688141

Last Updated: 2020-04-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28304 participants
• Primary outcome timeframe: Baseline and 3.5 years
• Results posted on: 2020-04-08

Participant Flow

Participant milestones

Measure	Control Usual care	Enhanced Management Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed. Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Overall Study STARTED	11706	11651
Overall Study COMPLETED	11706	11651
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Control n=11706 Participants Usual care	Enhanced Management n=11651 Participants Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed. Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.	Total n=23357 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	11706 Participants n=5 Participants	11651 Participants n=7 Participants	23357 Participants n=5 Participants
Age, Continuous	75.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	75.1 years STANDARD_DEVIATION 11.4 • n=7 Participants	75.3 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	7285 Participants n=5 Participants	7234 Participants n=7 Participants	14519 Participants n=5 Participants
Sex: Female, Male Male	4421 Participants n=5 Participants	4417 Participants n=7 Participants	8838 Participants n=5 Participants
Region of Enrollment United Kingdom	11706 participants n=5 Participants	11651 participants n=7 Participants	23357 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3.5 years

Outcome measures

Measure	Control n=11706 Participants Usual care	Enhanced Management n=11651 Participants Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed. Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study	-2.00 mean average eGFR change/mL/min/1.73 m^2 Interval -3.95 to 0.92	-2.29 mean average eGFR change/mL/min/1.73 m^2 Interval -3.89 to -0.69

SECONDARY outcome

Timeframe: Baseline and 3.5 years

Population: Denominator change due to loss to follow-up and death.

Observation of blood pressure control over the study period via blood pressure targets

Outcome measures

Measure	Control n=11551 Participants Usual care	Enhanced Management n=11473 Participants Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed. Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Blood Pressure Control Baseline	6834 Participants	7137 Participants
Blood Pressure Control 3.5 Years	7460 Participants	7295 Participants

SECONDARY outcome

Timeframe: 3.5 years

Population: Loss to follow-up and death

Proteinuria coding in practices

Outcome measures

Measure	Control n=11689 Participants Usual care	Enhanced Management n=11546 Participants Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed. Enhanced management: Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Proteinuria Baseline	627 participants	982 participants
Proteinuria 3.5 Years	1947 participants	2110 participants

SECONDARY outcome

Timeframe: 3.5 years

Population: Data not available for analysis.

Observation of incidence of cardiovascular events over the study period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3.5 years

Population: Data not available for analysis.

Nature and incidence over the study period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3.5 years

Population: Data not available for analysis.

Data coillected from secondary care

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3.5 years

Population: Data not available for analysis.

data collected from secondary care

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Nigel Brunskill

University of Leicester

Phone: +44 116 258 8043

Email: njb18@le.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place