Trial Outcomes & Findings for Improving Adherence in Nonadherent Kidney Transplant Patients (NCT NCT03892317)

Last Updated: 2024-12-05

Results Overview

Immunosuppression Medication adherence will be assessed and compared using the BAASIS questionnaire at recruitment and at the end of the study. The BAASIS questionnaire is a closed question questionnaire (either adherent or non-adherent); it is validated for assessing immunosuppression nonadherence in transplant patients. Any patient answering yes to any of the questions is assessed to be nonadherent

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

One year

Results posted on

2024-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Medication Adherence Interventions Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Overall Study STARTED	42
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Adherence in Nonadherent Kidney Transplant Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medication Adherence Interventions n=42 Participants Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Age, Customized Age at Transplant	52.27 years n=5 Participants
Age, Customized Age at Recruitment	58.45 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Race/Ethnicity, Customized Black	13 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	18 Participants n=5 Participants
Race/Ethnicity, Customized Indoasian	9 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Region of Enrollment United Kingdom	42 participants n=5 Participants
Marital Status Cohabiting	2 Participants n=5 Participants
Marital Status Divorced	4 Participants n=5 Participants
Marital Status Married	27 Participants n=5 Participants
Marital Status Single	7 Participants n=5 Participants
Marital Status Widowed	2 Participants n=5 Participants
Education Status A levels/B Tec	11 Participants n=5 Participants
Education Status Degree	11 Participants n=5 Participants
Education Status GCSE / O Levels	12 Participants n=5 Participants
Education Status Higher Degree	2 Participants n=5 Participants
Education Status No Qualification	6 Participants n=5 Participants
Graft Type Living Donor	22 Participants n=5 Participants
Graft Type Deceased Donor	20 Participants n=5 Participants
Dialysis Modality HD	26 Participants n=5 Participants
Dialysis Modality PD	2 Participants n=5 Participants
Dialysis Modality Pre-emptive	14 Participants n=5 Participants
Cause of ESRD APKD	6 Participants n=5 Participants
Cause of ESRD DM	7 Participants n=5 Participants
Cause of ESRD GN	12 Participants n=5 Participants
Cause of ESRD Other	9 Participants n=5 Participants
Cause of ESRD Unknown	6 Participants n=5 Participants
Cause of ESRD Urological	2 Participants n=5 Participants
Diabetes Yes	15 Participants n=5 Participants
Diabetes No	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Any patient answering yes to any of the questions is assessed to be nonadherent. Results are reported at time 0 (baseline), time 3 months, time 6 months, time 9 months, and time 12 months.

Outcome measures

Outcome measures
Measure	Medication Adherence Interventions n=42 Participants Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Change in Number of Patients Being Adherent/Non-aherent After the Intervention Adherent (Time 0)	15 Participants
Change in Number of Patients Being Adherent/Non-aherent After the Intervention Adherent (Time 3 months)	30 Participants
Change in Number of Patients Being Adherent/Non-aherent After the Intervention Adherent (Time 6 months)	34 Participants
Change in Number of Patients Being Adherent/Non-aherent After the Intervention Adherent (Time 9 months)	35 Participants
Change in Number of Patients Being Adherent/Non-aherent After the Intervention Adherent (Time 12 months)	36 Participants

PRIMARY outcome

Timeframe: One year

Intrapatient variability of tacrolimus levels will be measured and compared and reported as percentage difference

Outcome measures

Outcome measures
Measure	Medication Adherence Interventions n=42 Participants Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Change in the Median IPV Before and After the Intervention	32.03 % difference Interval -22.61 to 80.83

PRIMARY outcome

Timeframe: One year

Population: Patients were not analysed for this outcome

Data for this outcome measure has not been analysed: originally the outpatient clinic nonattendance rate was to be assessed and compared during the 12 months prior to recruitment to the study and during the study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: No biopsies were indicated throughout the study

Number of patients who develop biopsy proven ACR/AMR

Outcome measures

Outcome measures
Measure	Medication Adherence Interventions n=42 Participants Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Biopsy Proven ACR / AMR	0 Participants

SECONDARY outcome

Timeframe: One year

Population: Some patients who had readmissions had more than one readmission.

The number of readmissions and their reasons why during the study will be recorded

Outcome measures

Outcome measures
Measure	Medication Adherence Interventions n=42 Participants Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
The Number of Readmissions Number of readmissions associated with the study	0 Participants
The Number of Readmissions Number of patients who had readmissions	12 Participants
The Number of Readmissions Number of patients who didn't have readmissions	30 Participants

SECONDARY outcome

Timeframe: One year

For secondary outcome measures 6\&7 - no one developed a Donor Specific Antibody (DSA) or Transplant Glomerulopathy, Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change. Number of patients who develop a DSA or transplant glomerulopathy (CNI) toxicity or diabetic change on biopsy

Outcome measures

Outcome measures
Measure	Medication Adherence Interventions n=42 Participants Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Donor Specific Antibody (DSA) or Transplant Glomerulopathy	0 number of interventions

SECONDARY outcome

Timeframe: One year

For secondary outcome measures 6\&7 - No biopsies were indicated throughout the study therefore no one developed Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change Number of patients who develop fibrosis, hyalinosis, calcineurin inhibitor

Outcome measures

Outcome measures
Measure	Medication Adherence Interventions n=42 Participants Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change on Toxicity	0 number of interventions

SECONDARY outcome

Timeframe: One year

Number of patients who lose their graft

Outcome measures

Outcome measures
Measure	Medication Adherence Interventions n=42 Participants Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Graft Loss	0 Participants

SECONDARY outcome

Timeframe: One year

Number of patients who die

Outcome measures

Outcome measures
Measure	Medication Adherence Interventions n=42 Participants Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Death	0 Participants

SECONDARY outcome

Timeframe: One year

Change in serum creatinine at the end of the study Data for this outcome measure has not been analysed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Change in eGFR at the end of the study. Data for this outcome measure has not been analysed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Change in proteinuria at the end of the study. Data for this outcome measure has not been analysed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Change in haematocrit at the end of the study. Data for this outcome measure has not been analysed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Change in haemoglobin at the end of the study. Data for this outcome measure has not been analysed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Change in albumin at the end of the study. Data for this outcome measure has not been analysed

Outcome measures

Outcome data not reported

Adverse Events

Medication Adherence Interventions

Serious events: 14 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Medication Adherence Interventions n=42 participants at risk Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Renal and urinary disorders Infection - Tx kidney	4.8% 2/42 • Number of events 2 • 1 yr circa There are no significant adverse events attributed to the study.
Renal and urinary disorders Infection - native kidney	4.8% 2/42 • Number of events 2 • 1 yr circa There are no significant adverse events attributed to the study.
Reproductive system and breast disorders Infection - Tx gynae	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Respiratory, thoracic and mediastinal disorders Infection - chest	4.8% 2/42 • Number of events 2 • 1 yr circa There are no significant adverse events attributed to the study.
Gastrointestinal disorders Infection - colecystis	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Vascular disorders ITP	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Metabolism and nutrition disorders NODAT	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Surgical and medical procedures Elective Surgery	4.8% 2/42 • Number of events 2 • 1 yr circa There are no significant adverse events attributed to the study.
Musculoskeletal and connective tissue disorders Pain - Ostheopatic fracture spine	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Vascular disorders Angioedema and hyponatraemia	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.

Other adverse events

Other adverse events
Measure	Medication Adherence Interventions n=42 participants at risk Pharmacist led medication adherence interventions which will be tailored to individual patient need Pharmacist led medication adherence interventions: Medication adherence interventions which will be tailored to individual patient need
Renal and urinary disorders Infection - colecystitis	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Infections and infestations Infection - EBV	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Infections and infestations Infection - COVID (loss of sense of taste and smell)	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Gastrointestinal disorders Vomiting	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Musculoskeletal and connective tissue disorders Pain - hip and knee pain	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Musculoskeletal and connective tissue disorders Pain - generalised aches and pains	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Gastrointestinal disorders Pain - hernia	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
General disorders Swollen hand - possible gout	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
General disorders Fall	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Surgical and medical procedures NODAT - new diagnosis	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
General disorders AKI and high tacrolimus levels post ibuprofen ingestion	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Surgical and medical procedures Kidney biopsy - no new changes	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Vascular disorders Hypertensive	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Vascular disorders Thrombocytopenia in relation to ITP	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Surgical and medical procedures BCC removal	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Skin and subcutaneous tissue disorders Bowens disease - new diagnosis	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Skin and subcutaneous tissue disorders Heamorrhagic cyst	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
General disorders Increased frequency of nightmares	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Surgical and medical procedures Colonoscopy to investigate iron deficiency anaemia	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Surgical and medical procedures OGD as pre-planned procedure	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Renal and urinary disorders Flexible cystoscopy - enlarged prostate (benign)	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Psychiatric disorders Concern expressed by patient over memory decline	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Vascular disorders Worsening symptoms of established SVCO	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Reproductive system and breast disorders Erectile dysfunction	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Blood and lymphatic system disorders Hypocalcaemia	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
General disorders Lump at site of flu vaccine	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
General disorders Intermittent itch - resolved	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Immune system disorders Hayfever	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Metabolism and nutrition disorders Loss of appetite	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Surgical and medical procedures Hysteroscopic removal of IUD as an OP	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
General disorders SAD	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Surgical and medical procedures Carotid endarterectomy as elective procedure - preplanned	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Immune system disorders Intolerant of doxazosin	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Surgical and medical procedures Cateract removal - preplanned	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Gastrointestinal disorders Constipation	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Surgical and medical procedures Keloid scar removal as OP daycase - longstanding	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Metabolism and nutrition disorders Weight increase	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Skin and subcutaneous tissue disorders Mouth ulcer	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.
Gastrointestinal disorders Sclerosing mesenteritis	2.4% 1/42 • Number of events 1 • 1 yr circa There are no significant adverse events attributed to the study.

Additional Information

Goodall Dawn

Imperial College Healthcare Trust

Phone: +44 (0)20 7589 5111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place