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CompletedNCT03892317Updated Dec 5, 2024Results posted

Improving Adherence in Nonadherent Kidney Transplant Patients

An interventional study of Pharmacist led medication adherence interventions in Medication Adherence and Kidney Transplantation, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Imperial College London · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2018, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

This study will be undertaken using a prospective, multidimensional design. 42 nonadherent kidney transplant patients will be included in the intervention group. The nonadherent patients will be identified through Imperial College Renal and Transplant Centre (ICRTC) Outpatient Clinic based at Hammersmith Hospital. Standard and transplant specific demographics will be collected for all patients. All kidney transplant patients have their tacrolimus levels measured at each clinic visit. The variability of these levels can be used as a marker of their adherence. Patients with a high intrapatient variability (IPV) of their levels are said to be nonadherent. The Chief Investigator or another member of the research team will approach individual patients directly in the transplant out-patient clinic where they are members of the multidisciplinary clinical care team. The Chief Investigator or another member of the research team may also telephone patients to invite them to clinic to discuss participation in the trial. The Chief Investigator or another member of the research team will describe the study to the patient, answer any questions they have and provide them with a participant information sheet (PIS). Patients will be given the opportunity to take the PIS away and think about whether they would like to participate. A follow up discussion either in clinic or on the phone will be arranged with the patient to answer any queries they have within two weeks of providing them with the PIS; during that discussion, the Chief Investigator or other member of the research team will arrange an appointment in the transplant clinic with the patient to sign the consent form if they do decide to participate. Patients recruited into the study will receive pharmacist led, patient tailored interventions to improve immunosuppressant medication adherence. Patients will be included in the study for one year from recruitment.

The pharmacist led, patient tailored intervention will involve regular, intensive, personalised support from a pharmacist to improve adherence to immunosuppressive medications. The pharmacist will meet with the patient on a regular basis in the transplant clinic to identify their perceptual and practical barriers to adherence and agree a support plan that is tailored to them.

Within the first two weeks of recruitment, the study pharmacist will meet with the patient in transplant clinic to:

  • Undertake a full medication history
  • Discuss self-reported medication nonadherence
  • Undertake the BAASIS questionnaire
  • Ask the patient to complete a Beliefs about Medicines Questionnaire (BMQ)
  • Undertake a socioeconomic and educational assessment
  • Undertake to gain collateral reporting of nonadherence by clinicians, relatives, friends or carers
  • Perform a tacrolimus pill count
  • Check in-house dispensing records of tacrolimus
  • Identify barriers to adherence
  • Tailor interventions and support to the needs of the patient
  • Complete a motivational interview
  • Agree to meet again during an outpatient clinic visit within an agreed time which is appropriate for the patient needs and within 3 months.

This first visit will provide a baseline assessment of the patient's medication adherence.

Tailored support may include:

  • Setting alarms
  • Medication diary card or calendar
  • Medication compliance aid filled by the patient, family/carers or by a pharmacy professional
  • Adherence app
  • Reducing the complexity of the medication regime
  • Positioning medication within their daily routine eg. by toothbrush
  • Changing formulations
  • Additional education regarding need for medication / timing of doses
  • Referral to a social worker to assist with affordability of medicines
  • Referral to a psychologist to explore deeper psychological issues regarding medicines taking

The structure of each follow up adherence review will be the same as the first formal adherence review with the exception that the BMQ will only be repeated at the end of the one year follow-up and the socioeconomic and educational assessment will only be undertaken at the first assessment review. Every patient will have a formal adherence assessment at recruitment and then at 3, 6, 9 and 12 months. At the end of one year of follow-up, the specific benefits perceived by the patient of intensive adherence support from a pharmacist will be determined through a questionnaire.

Baseline nonadherence will be measured at the first visit with the study pharmacist within two weeks of recruitment and then at 3, 6, 9 and 12 months. The IPV of their tacrolimus levels and their outpatient clinic nonattendance rate will be measured retrospectively in the 12 months prior to recruitment to the study and then prospectively at the end of the intervention year. The IPV is calculated from the tacrolimus levels measured for an individual patient using the coefficient of variance mathematical formula - Coefficient of variance (COV) defined as: SD x 100 / Mean. The outpatient clinic nonattendance for each participant will be taken from the hospital integrated computer system.

02

Conditions studied

  • Medication Adherence
  • Kidney Transplantation
03

In context

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult kidney transplant patients (18 years of age and above)
  • Kidney transplant patients with an IPV of tacrolimus levels of greater than 18.15% in the previous 12 months

Exclusion criteria

Exclusion Criteria:

  • Antibody incompatible transplants including patients with preformed HLA and blood group incompatible
  • Previous rejection
  • Donor specific antibody positive
  • HIV positive patients
  • Simultaneous pancreas and kidney patients
  • Paediatric patients (less than 18 years of age)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Other
    Medication adherence interventions

    Pharmacist led medication adherence interventions which will be tailored to individual patient need

    Behavioral: Pharmacist led medication adherence interventions

Interventions

  • BehavioralPharmacist led medication adherence interventions

    Medication adherence interventions which will be tailored to individual patient need

06

What researchers measure

Primary outcomes

  1. Change in Number of Patients Being Adherent/Non-aherent After the Intervention

    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

    Time frame: One year

  2. Change in the Median IPV Before and After the Intervention

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

    Time frame: One year

  3. Change in Outpatient Clinic Nonattendance Rate Before and After the Intervention

    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

    Time frame: One year

Secondary outcomes

  1. Biopsy Proven ACR / AMR

    Number of patients who develop biopsy proven ACR/AMR

    Time frame: One year

  2. The Number of Readmissions

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

    Time frame: One year

  3. Donor Specific Antibody (DSA) or Transplant Glomerulopathy

    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

    Time frame: One year

  4. Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change on Toxicity

    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

    Time frame: One year

  5. Graft Loss

    Number of patients who lose their graft

    Time frame: One year

  6. Death

    Number of patients who die

    Time frame: One year

  7. Serum Creatinine

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

    Time frame: One year

  8. eGFR

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

    Time frame: One year

  9. Proteinuria

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

    Time frame: One year

  10. Haematocrit

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

    Time frame: One year

  11. Haemoglobin

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

    Time frame: One year

  12. Albumin

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

    Time frame: One year

07

Results

Posted Dec 5, 2024

Participant flow

Participant flow — Overall Study
MilestoneMedication Adherence Interventions
Started42
Completed42
Not completed0

Outcome measures

PrimaryChange in Number of Patients Being Adherent/Non-aherent After the Intervention

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

Time frame:
One year
Reported as:
Count of participants · Participants
Change in Number of Patients Being Adherent/Non-aherent After the Intervention
ParticipantsMedication Adherence Interventions
Adherent (Time 0)15
Adherent (Time 3 months)30
Adherent (Time 6 months)34
Adherent (Time 9 months)35
Adherent (Time 12 months)36
PrimaryChange in the Median IPV Before and After the Intervention

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

Time frame:
One year
Reported as:
Mean · % difference
Change in the Median IPV Before and After the Intervention
% differenceMedication Adherence Interventions
Change in the Median IPV Before and After the Intervention32.03 (-22.61 to 80.83)
PrimaryChange in Outpatient Clinic Nonattendance Rate Before and After the Intervention

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

Time frame:
One year

No measurements were reported for this outcome.

SecondaryBiopsy Proven ACR / AMR

Number of patients who develop biopsy proven ACR/AMR

Time frame:
One year
Reported as:
Count of participants · Participants
Biopsy Proven ACR / AMR
ParticipantsMedication Adherence Interventions
Biopsy Proven ACR / AMR0
SecondaryThe Number of Readmissions

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

Time frame:
One year
Reported as:
Count of participants · Participants
The Number of Readmissions
ParticipantsMedication Adherence Interventions
Number of readmissions associated with the study0
Number of patients who had readmissions12
Number of patients who didn't have readmissions30
SecondaryDonor Specific Antibody (DSA) or Transplant Glomerulopathy

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

Time frame:
One year
Reported as:
Number · number of interventions
Donor Specific Antibody (DSA) or Transplant Glomerulopathy
number of interventionsMedication Adherence Interventions
Donor Specific Antibody (DSA) or Transplant Glomerulopathy0
SecondaryFibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change on Toxicity

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

Time frame:
One year
Reported as:
Number · number of interventions
Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change on Toxicity
number of interventionsMedication Adherence Interventions
Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change on Toxicity0
SecondaryGraft Loss

Number of patients who lose their graft

Time frame:
One year
Reported as:
Count of participants · Participants
Graft Loss
ParticipantsMedication Adherence Interventions
Graft Loss0
SecondaryDeath

Number of patients who die

Time frame:
One year
Reported as:
Count of participants · Participants
Death
ParticipantsMedication Adherence Interventions
Death0
SecondarySerum Creatinine

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

Time frame:
One year

Results for this outcome have not been posted.

SecondaryeGFR

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

Time frame:
One year

Results for this outcome have not been posted.

SecondaryProteinuria

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

Time frame:
One year

Results for this outcome have not been posted.

SecondaryHaematocrit

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

Time frame:
One year

Results for this outcome have not been posted.

SecondaryHaemoglobin

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

Time frame:
One year

Results for this outcome have not been posted.

SecondaryAlbumin

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

Time frame:
One year

Results for this outcome have not been posted.

Adverse events

Collected over 1 yr circa. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Medication Adherence Interventions0/42 (0%)14/42 (33.3%)38/42 (90.5%)
Most frequent serious events
Most frequent serious events
EventMedication Adherence Interventions
Infection - Tx kidneyRenal and urinary disorders2/42
Infection - native kidneyRenal and urinary disorders2/42
Infection - chestRespiratory, thoracic and mediastinal disorders2/42
Elective SurgerySurgical and medical procedures2/42
Infection - Tx gynaeReproductive system and breast disorders1/42
Infection - colecystisGastrointestinal disorders1/42
ITPVascular disorders1/42
NODATMetabolism and nutrition disorders1/42
Pain - Ostheopatic fracture spineMusculoskeletal and connective tissue disorders1/42
Angioedema and hyponatraemiaVascular disorders1/42
Most frequent other events
Showing 10 of 39
Most frequent other events
EventMedication Adherence Interventions
Infection - colecystitisRenal and urinary disorders1/42
Infection - EBVInfections and infestations1/42
Infection - COVID (loss of sense of taste and smell)Infections and infestations1/42
VomitingGastrointestinal disorders1/42
Pain - hip and knee painMusculoskeletal and connective tissue disorders1/42
Pain - generalised aches and painsMusculoskeletal and connective tissue disorders1/42
Pain - herniaGastrointestinal disorders1/42
Swollen hand - possible goutGeneral disorders1/42
FallGeneral disorders1/42
NODAT - new diagnosisSurgical and medical procedures1/42

Baseline characteristics

Age, Customized
Age, Customized(years)Medication Adherence Interventions
Age at Transplant52.27 (43.89 to 60.65)
Age at Recruitment58.45 (49.84 to 67.06)
Sex: Female, Male
Sex: Female, Male(Participants)Medication Adherence Interventions
Female14
Male28
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Medication Adherence Interventions
Black13
Caucasian18
Indoasian9
Other2
Region of Enrollment
Region of Enrollment(participants)Medication Adherence Interventions
United Kingdom42
Marital Status
Marital Status(Participants)Medication Adherence Interventions
Cohabiting2
Divorced4
Married27
Single7
Widowed2
Education Status
Education Status(Participants)Medication Adherence Interventions
A levels/B Tec11
Degree11
GCSE / O Levels12
Higher Degree2
No Qualification6
Graft Type
Graft Type(Participants)Medication Adherence Interventions
Living Donor22
Deceased Donor20
Dialysis Modality
Dialysis Modality(Participants)Medication Adherence Interventions
HD26
PD2
Pre-emptive14

2 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Imperial College Renal and Transplant Centre
    London, W12 0HS, United Kingdom
09

References and documents

Publications

  • De Bleser L, Matteson M, Dobbels F, Russell C, De Geest S. Interventions to improve medication-adherence after transplantation: a systematic review. Transpl Int. 2009 Aug;22(8):780-97. doi: 10.1111/j.1432-2277.2009.00881.x. Epub 2009 Apr 6. PubMed 19386076 ↗
  • Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x. PubMed 19845597 ↗
  • Denhaerynck K, Steiger J, Bock A, Schafer-Keller P, Kofer S, Thannberger N, De Geest S. Prevalence and risk factors of non-adherence with immunosuppressive medication in kidney transplant patients. Am J Transplant. 2007 Jan;7(1):108-16. doi: 10.1111/j.1600-6143.2006.01611.x. Epub 2006 Nov 15. PubMed 17109727 ↗
  • Fine RN, Becker Y, De Geest S, Eisen H, Ettenger R, Evans R, Rudow DL, McKay D, Neu A, Nevins T, Reyes J, Wray J, Dobbels F. Nonadherence consensus conference summary report. Am J Transplant. 2009 Jan;9(1):35-41. doi: 10.1111/j.1600-6143.2008.02495.x. PubMed 19133930 ↗
  • Gaston RS, Hudson SL, Ward M, Jones P, Macon R. Late renal allograft loss: noncompliance masquerading as chronic rejection. Transplant Proc. 1999 Jun;31(4A):21S-23S. doi: 10.1016/s0041-1345(99)00118-9. No abstract available. PubMed 10372038 ↗
  • Morrissey PE, Flynn ML, Lin S. Medication noncompliance and its implications in transplant recipients. Drugs. 2007;67(10):1463-81. doi: 10.2165/00003495-200767100-00007. PubMed 17600393 ↗
  • Morrissey PE, Reinert S, Yango A, Gautam A, Monaco A, Gohh R. Factors contributing to acute rejection in renal transplantation: the role of noncompliance. Transplant Proc. 2005 Jun;37(5):2044-7. doi: 10.1016/j.transproceed.2005.03.017. PubMed 15964334 ↗
  • Prendergast MB, Gaston RS. Optimizing medication adherence: an ongoing opportunity to improve outcomes after kidney transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1305-11. doi: 10.2215/CJN.07241009. Epub 2010 May 6. PubMed 20448067 ↗
  • Schafer-Keller P, Steiger J, Bock A, Denhaerynck K, De Geest S. Diagnostic accuracy of measurement methods to assess non-adherence to immunosuppressive drugs in kidney transplant recipients. Am J Transplant. 2008 Mar;8(3):616-26. doi: 10.1111/j.1600-6143.2007.02127.x. PubMed 18294158 ↗
  • Wiebe C, Nevins TE, Robiner WN, Thomas W, Matas AJ, Nickerson PW. The Synergistic Effect of Class II HLA Epitope-Mismatch and Nonadherence on Acute Rejection and Graft Survival. Am J Transplant. 2015 Aug;15(8):2197-202. doi: 10.1111/ajt.13341. Epub 2015 Jun 11. PubMed 26095765 ↗
  • Sellares J, de Freitas DG, Mengel M, Reeve J, Einecke G, Sis B, Hidalgo LG, Famulski K, Matas A, Halloran PF. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012 Feb;12(2):388-99. doi: 10.1111/j.1600-6143.2011.03840.x. Epub 2011 Nov 14. PubMed 22081892 ↗
  • Roberts DM, Jiang SH, Chadban SJ. The treatment of acute antibody-mediated rejection in kidney transplant recipients-a systematic review. Transplantation. 2012 Oct 27;94(8):775-83. doi: 10.1097/TP.0b013e31825d1587. PubMed 23032865 ↗
  • Wiebe C, Gibson IW, Blydt-Hansen TD, Karpinski M, Ho J, Storsley LJ, Goldberg A, Birk PE, Rush DN, Nickerson PW. Evolution and clinical pathologic correlations of de novo donor-specific HLA antibody post kidney transplant. Am J Transplant. 2012 May;12(5):1157-67. doi: 10.1111/j.1600-6143.2012.04013.x. Epub 2012 Mar 19. PubMed 22429309 ↗
  • Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant. 2009 Nov;9(11):2597-606. doi: 10.1111/j.1600-6143.2009.02798.x. PubMed 19843035 ↗
  • Butler JA, Roderick P, Mullee M, Mason JC, Peveler RC. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review. Transplantation. 2004 Mar 15;77(5):769-76. doi: 10.1097/01.tp.0000110408.83054.88. PubMed 15021846 ↗
  • Massey EK, Tielen M, Laging M, Timman R, Beck DK, Khemai R, van Gelder T, Weimar W. Discrepancies between beliefs and behavior: a prospective study into immunosuppressive medication adherence after kidney transplantation. Transplantation. 2015 Feb;99(2):375-80. doi: 10.1097/TP.0000000000000608. PubMed 25606787 ↗
  • Massey EK, Tielen M, Laging M, Beck DK, Khemai R, van Gelder T, Weimar W. The role of goal cognitions, illness perceptions and treatment beliefs in self-reported adherence after kidney transplantation: a cohort study. J Psychosom Res. 2013 Sep;75(3):229-34. doi: 10.1016/j.jpsychores.2013.07.006. Epub 2013 Aug 3. PubMed 23972411 ↗
  • Dew MA, DiMartini AF, De Vito Dabbs A, Myaskovsky L, Steel J, Unruh M, Switzer GE, Zomak R, Kormos RL, Greenhouse JB. Rates and risk factors for nonadherence to the medical regimen after adult solid organ transplantation. Transplantation. 2007 Apr 15;83(7):858-73. doi: 10.1097/01.tp.0000258599.65257.a6. PubMed 17460556 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 31, 2017
  • Informed consent form · Feb 26, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03892317
Lead sponsor
Imperial College London
Responsible party
Sponsor
First posted
Mar 27, 2019
Start date
May 14, 2018
Primary completion
Jul 27, 2020
Completion
Jul 27, 2020
Results posted
Dec 5, 2024
Last update
Dec 5, 2024

Study contacts

Dawn Goodall
principal investigator · Imperial College Healthcare NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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