NCT03892317

Improving Adherence in Nonadherent Kidney Transplant Patients

Completed NA Results posted Last updated 5 December 2024

What this trial tests

NA trial testing Pharmacist led medication adherence interventions in Medication Adherence in 42 participants. Completed in 27 July 2020.

Timeline

14 May 2018

Primary endpoint
27 July 2020

27 July 2020

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	42
Start date	14 May 2018
Primary completion	27 July 2020
Estimated completion	27 July 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Pharmacist led medication adherence interventions

Conditions studied

• Medication Adherence — all drugs for Medication Adherence →
• Kidney Transplantation — all drugs for Kidney Transplantation →

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Medication Adherence or Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Number of Patients Being Adherent/Non-aherent After the Intervention Primary · One year

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

Adherent (Time 0)

Group	Value	95% CI
Medication Adherence Interventions	15

Adherent (Time 3 months)

Group	Value	95% CI
Medication Adherence Interventions	30

Adherent (Time 6 months)

Group	Value	95% CI
Medication Adherence Interventions	34

Adherent (Time 9 months)

Group	Value	95% CI
Medication Adherence Interventions	35

Adherent (Time 12 months)

Group	Value	95% CI
Medication Adherence Interventions	36

Change in the Median IPV Before and After the Intervention Primary · One year

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

Group	Value	95% CI
Medication Adherence Interventions	32.03	-22.61 – 80.83

Biopsy Proven ACR / AMR Secondary · One year

Number of patients who develop biopsy proven ACR/AMR

Group	Value	95% CI
Medication Adherence Interventions	0

The Number of Readmissions Secondary · One year

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

Group	Value	95% CI
Medication Adherence Interventions	0
Medication Adherence Interventions	12
Medication Adherence Interventions	30

Donor Specific Antibody (DSA) or Transplant Glomerulopathy Secondary · 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

Group	Value	95% CI
Medication Adherence Interventions	0

Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change on Toxicity Secondary · 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

Group	Value	95% CI
Medication Adherence Interventions	0

Graft Loss Secondary · One year

Number of patients who lose their graft

Group	Value	95% CI
Medication Adherence Interventions	0

Death Secondary · One year

Number of patients who die

Group	Value	95% CI
Medication Adherence Interventions	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 yr circa. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Medication Adherence Interventions

Serious: 14/42 (33%)

Deaths: 0/42

Serious adverse events (10 terms)

Reaction	System	Medication Adherence Inter…
Infection - Tx kidney	Renal and urinary disorders	—
Infection - native kidney	Renal and urinary disorders	—
Infection - chest	Respiratory, thoracic and mediastinal disorders	—
Elective Surgery	Surgical and medical procedures	—
Infection - Tx gynae	Reproductive system and breast disorders	—
Infection - colecystis	Gastrointestinal disorders	—
ITP	Vascular disorders	—
NODAT	Metabolism and nutrition disorders	—
Pain - Ostheopatic fracture spine	Musculoskeletal and connective tissue disorders	—
Angioedema and hyponatraemia	Vascular disorders	—

Other adverse events (39 terms — click to expand)

Reaction	System	Medication Adherence Inter…
Infection - colecystitis	Renal and urinary disorders	—
Infection - EBV	Infections and infestations	—
Infection - COVID (loss of sense of taste and smell)	Infections and infestations	—
Vomiting	Gastrointestinal disorders	—
Pain - hip and knee pain	Musculoskeletal and connective tissue disorders	—
Pain - generalised aches and pains	Musculoskeletal and connective tissue disorders	—
Pain - hernia	Gastrointestinal disorders	—
Swollen hand - possible gout	General disorders	—
Fall	General disorders	—
NODAT - new diagnosis	Surgical and medical procedures	—
AKI and high tacrolimus levels post ibuprofen ingestion	General disorders	—
Kidney biopsy - no new changes	Surgical and medical procedures	—
Hypertensive	Vascular disorders	—
Thrombocytopenia in relation to ITP	Vascular disorders	—
BCC removal	Surgical and medical procedures	—
Bowens disease - new diagnosis	Skin and subcutaneous tissue disorders	—
Heamorrhagic cyst	Skin and subcutaneous tissue disorders	—
Increased frequency of nightmares	General disorders	—
Colonoscopy to investigate iron deficiency anaemia	Surgical and medical procedures	—
OGD as pre-planned procedure	Surgical and medical procedures	—
Flexible cystoscopy - enlarged prostate (benign)	Renal and urinary disorders	—
Concern expressed by patient over memory decline	Psychiatric disorders	—
Worsening symptoms of established SVCO	Vascular disorders	—
Erectile dysfunction	Reproductive system and breast disorders	—
Hypocalcaemia	Blood and lymphatic system disorders	—
Lump at site of flu vaccine	General disorders	—
Intermittent itch - resolved	General disorders	—
Hayfever	Immune system disorders	—
Loss of appetite	Metabolism and nutrition disorders	—
Hysteroscopic removal of IUD as an OP	Surgical and medical procedures	—
SAD	General disorders	—
Carotid endarterectomy as elective procedure - preplanned	Surgical and medical procedures	—
Intolerant of doxazosin	Immune system disorders	—
Cateract removal - preplanned	Surgical and medical procedures	—
Constipation	Gastrointestinal disorders	—
Keloid scar removal as OP daycase - longstanding	Surgical and medical procedures	—
Weight increase	Metabolism and nutrition disorders	—
Mouth ulcer	Skin and subcutaneous tissue disorders	—
Sclerosing mesenteritis	Gastrointestinal disorders	—

Most-reported serious reactions: Infection - Tx kidney, Infection - native kidney, Infection - chest, Elective Surgery, Infection - Tx gynae, Infection - colecystis, ITP, NODAT.

Data from ClinicalTrials.gov NCT03892317 adverse events section.

Sponsor's own description

Organs for transplantation remain a scarce and precious resource with over 5000 patients currently on the kidney transplant waiting list. A kidney transplant costs approximately £17,000 in the first year and £5,000 per subsequent year. If the transplant fails, the patient must return to dialysis at an estimated cost of £30,800 per year or be retransplanted. While short term outcomes have improved steadily over the last 15-20 years, longer term outcomes haven't and after 10 years approximately 30% of kidney transplants have failed. Nonadherence to immunosuppressive medication is increasingly being associated with these poor long term outcomes and studies have estimated that 30- 50% of transplant patients are nonadherent to their immunosuppressive medication. The investigators want to determine whether immunosuppression medication adherence can be improved in a group of patients receiving tailored medication adherence support form a pharmacist. Adherence support will be provided for one year and will be individualised to each patient in the intervention group after identifying both their practical and perceptual barriers to adherence. The adherence interventions offered may include additional education and medication counselling, setting alarms, provision of a medication list, the use of a medications adherence app on a smart phone, reducing the number and frequency of tablets a patient takes or referral on to another health professional such as a social worker or psychologist for additional support. A range of clinical outcomes will be assessed for all patients on a regular basis in order to determine whether the provision of effective medication adherence support for the kidney transplant patients may help to optimise the long-term outcomes of these transplants

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.