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CompletedNCT04260464Updated Jan 22, 2024Results posted

Renal Impairment Study of PF-06700841

A Phase 1 interventional study of PF-06700841 in Healthy Volunteer and Renal Impairment, sponsored by Pfizer. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-22.

Sponsored by Pfizer · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney disease.

Read the detailed description

This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-06700841 after a single oral dose of 30 mg. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately 16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted with approximately 8 subjects each with moderate and mild renal impairment. The total duration of participation from Screening visit to Day 4 will be a maximum of 32 days and from Screening visit to Follow-up/Contact Visit will a maximum of 67 days.

02

Conditions studied

  • Healthy Volunteer
  • Renal Impairment

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Keywords

  • Pharmacokinetics
03

In context

Renal Insufficiency

1,994 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 30 is below the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or female participants who are between the ages of 18 and 75 years, inclusive, at the Screening visit.
  • Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight >50 kg.
  • Normal, Severe, Moderate and Mild renal function at 2 Screening visits.
  • Stable drug regimen

Exclusion criteria

Exclusion Criteria:

  • Renal transplant recipients.
  • Urinary incontinence without catheterization.
  • Subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior to first dose
  • Known history of pulmonary embolism or recurrent deep vein thrombosis
  • Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    PF-06700841 Severe Renal Impairment

    This arm includes participants with severe renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1

    Drug: PF-06700841

  • Experimental
    PF-06700841 Normal Renal Function

    This arm includes participants with normal renal function who will receive a single oral dose of 30 mg PF-06700841 on Day 1

    Drug: PF-06700841

  • Experimental
    PF-06700841 Moderate Renal Impairment

    This arm includes participants with moderate renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1

    Drug: PF-06700841

  • Experimental
    PF-06700841 Mild Renal Impairment

    This arm includes participants with mild renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1

    Drug: PF-06700841

Interventions

  • DrugPF-06700841

    A single dose of 30 mg PF-06700841 will be administered on Day 1

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

    Cmax is the maximum observed plasma concentration of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

  2. Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

    AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06700841 from the concentration-time data.

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

  3. Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

    Cmax is the maximum observed plasma concentration of PF-06802530 (M1), a major metabolite of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

  4. AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

    AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06802530 (M1), a major metabolite of PF-06700841 from the concentration-time data.

    Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

Secondary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Any events occurring following start of treatment or increasing in severity after the start of the treatment were counted as treatment emergent. An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect. Severe adverse events is an event that prevents normal everyday activities which is a category utilized for rating the intensity of an event.

    Time frame: From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)

  2. Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality

    The hematology, clinical chemistry and urinalysis abnormalities were summarized in accordance with the sponsor reporting standards without regard to baseline abnormality. Baseline is defined as the last planned predose measurement taken on Day -1.

    Time frame: Baseline (Day -1) and Day 4

  3. Number of Participants With Post-baseline Vital Sign Abnormalities

    Vital Signs were assessed against the criteria specified in the sponsor reporting standards for potential clinical concerns. Vital sign abnormalities criteria included: 1) Systolic blood pressure (BP) in millimeters of mercury (mmHg): \<90 mmHg with increase or decrease from baseline of ≥30 mmHg with high and low post baseline values; 2) Diastolic blood pressure (BP) (mmHg): \<50 mmHg with increase or decrease from baseline of ≥20 mmHg with high and low post baseline values; 3) Supine pulse rate in beats per minutes (bpm): \>120 or \<40 bpm. Categories with at least 1 participant having vital sign abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1.

    Time frame: Baseline (Day 1) and Day 4

  4. Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities

    ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): \> 450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60. Categories with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1.

    Time frame: 0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4

07

Results

Posted Jan 22, 2024

Participant flow

Healthy adult participants with normal renal function and adult participants with renal impairment were enrolled in this study.

Participant flow — Overall Study
MilestoneSevere Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal Impairment
Started8778
Completed8778
Not completed0000

Outcome measures

PrimaryMaximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

Cmax is the maximum observed plasma concentration of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.

Time frame:
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Reported as:
Geometric mean · ng/mL
Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
ng/mLSevere Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal Impairment
Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function303.2 ± 34275.2 ± 27341.8 ± 17260.3 ± 89
Statistical analysis
  • Severe Renal Impairment vs Normal Renal Function · Test/reference ratio: 110.15 · 95% CI 83.76 to 144.86
  • Normal Renal Function vs Mild Renal Impairment · Test/reference ratio: 94.58 · 90% CI 55.84 to 160.19
  • Normal Renal Function vs Moderate Renal Impairment · Test/reference ratio: 124.20 · 90% CI 100.24 to 153.89
PrimaryArea Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06700841 from the concentration-time data.

Time frame:
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Reported as:
Geometric mean · ng*hr/mL
Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
ng*hr/mLSevere Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal Impairment
Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function2013 ± 571796 ± 772652 ± 751274 ± 199
Statistical analysis
  • Severe Renal Impairment vs Normal Renal Function · Test/reference ratio: 112.08 · 95% CI 60.85 to 206.45
  • Normal Renal Function vs Mild Renal Impairment · Test/reference ratio: 70.97 · 90% CI 27.60 to 182.49
  • Normal Renal Function vs Moderate Renal Impairment · Test/reference ratio: 147.70 · 90% CI 75.17 to 290.21
PrimaryCmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

Cmax is the maximum observed plasma concentration of PF-06802530 (M1), a major metabolite of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.

Time frame:
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Reported as:
Geometric mean · ng/mL
Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
ng/mLSevere Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal Impairment
Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function250.4 ± 26141.0 ± 32172.1 ± 46187.1 ± 43
Statistical analysis
  • Severe Renal Impairment vs Normal Renal Function · Test/reference ratio: 177.53 · 95% CI 135.82 to 232.04
  • Normal Renal Function vs Mild Renal Impairment · Test/reference ratio: 132.69 · 90% CI 95.08 to 185.17
  • Normal Renal Function vs Moderate Renal Impairment · Test/reference ratio: 122.04 · 90% CI 84.47 to 176.30
PrimaryAUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function

AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06802530 (M1), a major metabolite of PF-06700841 from the concentration-time data.

Time frame:
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Reported as:
Geometric mean · ng*hr/mL
AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
ng*hr/mLSevere Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal Impairment
AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function7756 ± 411739 ± 243984 ± 152515 ± 32
Statistical analysis
  • Severe Renal Impairment vs Normal Renal Function · Test/reference ratio: 445.99 · 95% CI 326.55 to 609.13
  • Normal Renal Function vs Mild Renal Impairment · Test/reference ratio: 144.63 · 90% CI 112.76 to 185.50
  • Normal Renal Function vs Moderate Renal Impairment · Test/reference ratio: 229.12 · 90% CI 189.97 to 276.35
SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs)

Any events occurring following start of treatment or increasing in severity after the start of the treatment were counted as treatment emergent. An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect. Severe adverse events is an event that prevents normal everyday activities which is a category utilized for rating the intensity of an event.

Time frame:
From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
ParticipantsSevere Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal Impairment
Participants with adverse events2013
Participants with serious adverse events0000
Participants with severe adverse events0000
Participants discontinued from study due to adverse events0000
SecondaryNumber of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality

The hematology, clinical chemistry and urinalysis abnormalities were summarized in accordance with the sponsor reporting standards without regard to baseline abnormality. Baseline is defined as the last planned predose measurement taken on Day -1.

Time frame:
Baseline (Day -1) and Day 4
Reported as:
Count of participants · Participants
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
ParticipantsSevere Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal Impairment
Hematology-Hemoglobin (HGB) (g/dL) <0.8✕lower limit of normal (LLN)2000
Hematology-Hematocrit (%) <0.8✕LLN1000
Hematology-Erythrocytes (10^6/mm^3) <0.8✕LLN1000
Hematology- Erythromycin (Ery.) Mean Corpuscular HGB (pg/cell) >1.1✕upper limit of normal (ULN)1000
Hematology-Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9✕LLN0010
Hematology-Lymphocytes/Leukocytes (%) <0.8✕LLN1010
Hematology-Lymphocytes/Leukocytes (%) >1.2✕ULN0100
Hematology-Eosinophils/Leukocytes (%) >1.2✕ULN2000
Clinical chemistry-Blood Urea Nitrogen (mg/dL) >1.3✕ULN8020
Clinical chemistry-Creatinine (mg/dL) >1.3✕ULN8010
Clinical chemistry-Urate (mg/dL) > 1.2✕ULN5001
Clinical chemistry-Potassium (mEq/L) >1.1✕ULN0001
Clinical chemistry-Bicarbonate (mEq/L) <0.9✕LLN1000
Clinical chemistry-Glucose (mg/dL) >1.5✕ULN1042
Urinalysis-Urine Glucose ≥12011
Urinalysis-Urine Protein ≥12000
Urinalysis-Urine Hemoglobin ≥10001
Urinalysis-Urine Leukocyte Esterase ≥11102
SecondaryNumber of Participants With Post-baseline Vital Sign Abnormalities

Vital Signs were assessed against the criteria specified in the sponsor reporting standards for potential clinical concerns. Vital sign abnormalities criteria included: 1) Systolic blood pressure (BP) in millimeters of mercury (mmHg): \<90 mmHg with increase or decrease from baseline of ≥30 mmHg with high and low post baseline values; 2) Diastolic blood pressure (BP) (mmHg): \<50 mmHg with increase or decrease from baseline of ≥20 mmHg with high and low post baseline values; 3) Supine pulse rate in beats per minutes (bpm): \>120 or \<40 bpm. Categories with at least 1 participant having vital sign abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1.

Time frame:
Baseline (Day 1) and Day 4
Reported as:
Count of participants · Participants
Number of Participants With Post-baseline Vital Sign Abnormalities
ParticipantsSevere Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal Impairment
Number of Participants With Post-baseline Vital Sign Abnormalities0000
SecondaryNumber of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities

ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): \> 450, \>480, \>500, increase from baseline \>30, increase from baseline \>60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): \>450, \>480, \>500, increase from baseline \>30, increase from baseline \>60. Categories with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1.

Time frame:
0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4
Reported as:
Count of participants · Participants
Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities
ParticipantsSevere Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal Impairment
QTcB interval, single beat (msec): 450 < Value ≤ 4802013
QTcB interval, single beat (msec): 30 ≤ Change ≤ 600003
QTcF interval, single beat (msec): 450 < Value ≤ 4802110
QTcF interval, single beat (msec): 30 ≤ Change ≤ 600002

Adverse events

Collected over From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Severe Renal Impairment0/8 (0%)0/8 (0%)2/8 (25%)
Normal Renal Function0/7 (0%)0/7 (0%)0/7 (0%)
Moderate Renal Impairment0/7 (0%)0/7 (0%)1/7 (14.3%)
Mild Renal Impairment0/8 (0%)0/8 (0%)3/8 (37.5%)
Most frequent other events
Most frequent other events
EventSevere Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal Impairment
NauseaGastrointestinal disorders1/80/71/70/8
Abdominal distensionGastrointestinal disorders0/80/70/71/8
DiverticulitisInfections and infestations0/80/70/71/8
Flank painMusculoskeletal and connective tissue disorders0/80/70/71/8
DizzinessNervous system disorders1/80/70/70/8
HeadacheNervous system disorders0/80/70/71/8

Baseline characteristics

All enrolled participants who were assigned to investigational product and took at least 1 dose of investigational product.

Age, Continuous
Age, Continuous(Years)Severe Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal ImpairmentTotal
Mean (SD)65.9 ± 7.5762.4 ± 5.3868.4 ± 4.2461.5 ± 6.1664.5 ± 6.36
Age, Customized
Age, Customized(Participants)Severe Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal ImpairmentTotal
45-64 Years361616
>=65 Years516214
Sex: Female, Male
Sex: Female, Male(Participants)Severe Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal ImpairmentTotal
Female11248
Male765422
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Severe Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal ImpairmentTotal
White856827
Black or African American02103
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Severe Renal ImpairmentNormal Renal FunctionModerate Renal ImpairmentMild Renal ImpairmentTotal
Hispanic or Latino442414
Not Hispanic or Latino435416
08

Study locations

3 sites
  • Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy
    Miami, Florida 33136, United States
  • University of Miami Division of Clinical Pharmacology
    Miami, Florida 33136, United States
  • Prism Research LLC dba Nucleus Network
    Saint Paul, Minnesota 55114, United States
09

References and documents

Study documents

  • Study protocol · Nov 20, 2019
  • Statistical analysis plan · Feb 18, 2020

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

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04260464
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 7, 2020
Start date
Jul 3, 2020
Primary completion
May 4, 2022
Completion
May 4, 2022
Results posted
Jan 22, 2024
Last update
Jan 22, 2024

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

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

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