FAST PV and mGFR™ Technology in Congestive Heart Failure

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ClinicalTrials.gov Identifier: NCT03808948

Recruitment Status : Completed

First Posted : January 18, 2019

Results First Posted : November 17, 2021

Last Update Posted : November 17, 2021

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

FAST BioMedical

Information provided by (Responsible Party):

Kai Schmidt-Ott, Charite University, Berlin, Germany

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition	CHF
Intervention	Device: VFI
Enrollment	50

Participant Flow

Recruitment Details	A totally of 50 hospitalized patients were enrolled between January 10th, 2019 and August 15th, 2019.
Pre-assignment Details	No patients were excluded after enrollment but before assignment to the treatment group.


Arm/Group Title	All Patients
Arm/Group Description	VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description	VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Period Title: Overall Study
Started	50
Completed	50
Not Completed	0

Baseline Characteristics

Arm/Group Title		All Patients
Arm/Group Description		VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description		VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Overall Number of Baseline Participants		50
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	50 participants
		72.5 (13.72)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants
	Female	10 20.0%
	Male	40 80.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	50 participants
	American Indian or Alaska Native	0 0.0%
	Asian	2 4.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	48 96.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
Germany	Number Analyzed	50 participants
Germany		50
Weight day 1 (kg) Mean (Standard Deviation) Unit of measure: Kilograms
	Number Analyzed	50 participants
		89.21 (22.24)
Height day 1 (cm) Mean (Standard Deviation) Unit of measure: Centimeters
	Number Analyzed	50 participants
		172.84 (10.62)
BMI day 1 (kg/m2) Mean (Standard Deviation) Unit of measure: Kilograms / meter squared
	Number Analyzed	50 participants
		29.7 (6)

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Treatment Related AEs and Serious Adverse Events (SAEs)
Description	The percentage of treatment emergent SAEs considered to be surely rela...
Description	The percentage of treatment emergent SAEs considered to be surely related to the VFI should be zero.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	All Patients
Arm/Group Description:	VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description:	VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Overall Number of Participants Analyzed	50
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%

2.Primary Outcome


Title	Percentage Difference in Mean Plasma Concentration of FD003 Over the 15-, 30-, and 60-minute Blood Draws on Days 1 and 3
Description	Function of the FAST PV measurement will be assessed by determining th...
Description	Function of the FAST PV measurement will be assessed by determining the plasma stability of the FD003 high molecular weight marker over the 15, 30, and 60 minute blood draws and applying the following criteria: The FAST PV measurement is considered as stable, if the mean plasma concentration of FD003 at 30 minutes is not more than 10% lower than the mean plasma concentration at 15 minutes AND if the mean plasma concentration at 60 minutes is not more than 10% lower than the mean plasma concentration at 30 minutes We will determine the percentage of patients which show a decline in the plasma concentration of FD003 of more than 10% from 15min to 30min and separately from 30 min to 60min. This percentage should be ideally close to 0.
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	All Patients
Arm/Group Description:	VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description:	VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Overall Number of Participants Analyzed	50
Mean (Standard Deviation) Unit of Measure: Percent difference, plasma concentration
Difference between Day 1 mean plasma concentration of FD003 at 15 minutes and 30 minutes	-2.36 (7.94)
Difference between Day 3 mean plasma concentration of FD003 at 15 minutes and 30 minutes	-3.12 (11.29)
% difference between Day 1 mean plasma concentration of FD003 at 30 minutes and 60 minutes	-0.8 (5.6)
% difference between Day 3 mean plasma concentration of FD003 at 30 minutes and 60 minutes	-0.79 (8.67)

3.Secondary Outcome


Title	Accuracy Between Estimated PV (ePV) on Days 1 and 3 (by Established Measures) and Measured PV (mPV; as Assessed by FAST Methodology) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Description	The percentage difference between ePV and mPV were evaluated to consid...
Description	The percentage difference between ePV and mPV were evaluated to consider the percentage of the population with a <15% and <30% difference between ePV and mPV on day 1 and day 3
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

One patient did not have a hematocrit available for ePV determination, fourteen patients did not have day 3 measurements of mPV.


Arm/Group Title		All Patients
Arm/Group Description:		VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description:		VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Overall Number of Participants Analyzed		49
Measure Type: Count of Participants Unit of Measure: Participants
Number patients where ePV (Kaplan Hakim) was within 15% of mPV day1	Number Analyzed	49 participants
		32 65.3%
Number patients where ePV (Kaplan Hakim) was within 30% of mPV day 1	Number Analyzed	49 participants
		44 89.8%
Number patients where ePV (Kaplan Hakim) was within 15% of mPV day3	Number Analyzed	36 participants
		24 66.7%
Number patients where ePV (Kaplan Hakim) was within 30% of mPV day3	Number Analyzed	36 participants
		30 83.3%

4.Secondary Outcome


Title	Accuracy Between Estimated Total Blood Volume (TBV) on Days 1 and 3 and Measured TBV (mTBV; Calculated From mPV and Measured Hematocrit) Defined as the Percentage of the Population With a <15% and <30% Difference Between ePV and mPV
Description	Accuracy between the Nadler's Formula as an estimate of total blood vo...
Description	Accuracy between the Nadler's Formula as an estimate of total blood volume (TBV) and measured blood volume (mTBV) on days 1 and 3 as determined by the percentage of the population with a <15% and <30% difference between ePV and mPV
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

One patient did not have a hematocrit on day 1 for calculation of mTBV and eTBV, twelve patients did not receive a second measurement on day 3, two patients that recieved a second measurement, did not have a hematocrit on day 3 for calculation of mTBV and eTBV


Arm/Group Title		All Patients
Arm/Group Description:		VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description:		VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Overall Number of Participants Analyzed		49
Measure Type: Count of Participants Unit of Measure: Participants
Number of patients where eTBV was within 15% of mTBV value day1	Number Analyzed	49 participants
		32 65.3%
Number of patients where eTBV was within 30% of mTBV value day1	Number Analyzed	49 participants
		45 91.8%
Number of patients where eTBV was within 15% of mTBV value day3	Number Analyzed	36 participants
		25 69.4%
Number of patients where eTBV was within 30% of mTBV value day3	Number Analyzed	36 participants
		32 88.9%

5.Secondary Outcome


Title	Accuracy of eGFR Determined by CKD-EPI-SCr and mGFR on Day 1 and Day 3 Defined the Percentage of the Population With a <15% and <30% Difference Between eGFR and mGFR
Description	To evaluate whether estimated Glomerular Filtration Rate (eGFR) (calcu...
Description	To evaluate whether estimated Glomerular Filtration Rate (eGFR) (calculation by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) on days 1 and 3 provides an accurate estimate of measured GFR (mGFR; assessed by FAST methodology) in heart failure patients under-going active fluid management, determined by the percentage of patients with a <15% and <30% difference between eGFR and mGFR
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

twelve patients did not have mGFR measurement on day 3, so only 38 patients are analyzed on day 3


Arm/Group Title		All Patients
Arm/Group Description:		VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description:		VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Overall Number of Participants Analyzed		50
Measure Type: Count of Participants Unit of Measure: Participants
Number of patients where eGFR was within 15% of mGFR value on Day 1.	Number Analyzed	50 participants
		20 40.0%
Number of patients where eGFR was within 15% of mGFR value on Day 3.	Number Analyzed	38 participants
		10 26.3%
Number of patients where eGFR was within 30% of mGFR value on Day 1.	Number Analyzed	50 participants
		33 66.0%
Number of patients where eGFR was within 30% of mGFR value on Day 3.	Number Analyzed	38 participants
		24 63.2%

6.Secondary Outcome


Title	Percentage of the Population That Developed Acute Kidney Injury (AKI) Within the Following 48-72 Hour and Prediction of AKI by mGFR/eGFR Ratio on Days 1 and 3
Description	To evaluate the percentage of patients developing acute kidney injury ...
Description	To evaluate the percentage of patients developing acute kidney injury (AKI) within the following 48-72 hours on day 1 and day 3 and to evaluate whether patients with a low mGFR/eGFR ratio on days 1 and 3 are at higher risk of developing acute kidney injury (AKI) within the following 48-72 hours using a binary logisitic regression with AKI as binary outcome and mGFR/eGFR as independent variate
Time Frame	48-72h

Outcome Measure Data

Analysis Population Description

36 patients had data for AKI determination 48h after day 1, 32 patients had data for AKI determination after day 3


Arm/Group Title		All Patients
Arm/Group Description:		VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description:		VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Overall Number of Participants Analyzed		36
Measure Type: Count of Participants Unit of Measure: Participants
Number of patients with AKI within 48h after day 1	Number Analyzed	36 participants
Number of patients with AKI within 48h after day 1		17 47.2%
Number of patients with AKI within 48h after day 3	Number Analyzed	32 participants
Number of patients with AKI within 48h after day 3		11 34.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	All Patients
	Comments	Binary logistic regression with mGFR/eGFR ratio as independent variate, AKI as binary outcome
	Type of Statistical Test	Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.4842
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95% 0.08 to 1.97
	Estimation Comments	[Not Specified]

7.Secondary Outcome


Title	Percentage of Patients Who Are Refractory to Diuretic Therapy
Description	Being refractory to diuretic therapy (defined as any dosage increases ...
Description	Being refractory to diuretic therapy (defined as any dosage increases of furosemide i.v. dose equivalent, adding thiazide after day 1, requirement of ultrafiltration/RRT within the next 24-48 hours, failure to improve subjectively in PGA and dyspnoea scales, failure of mean weight loss during the study period Day 1-Day 5 of at least 0,5 kg/d).
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

one patient did not have weight data, two patients were discharged after first measurement (day 1) so no lineary observation was possible


Arm/Group Title	All Patients
Arm/Group Description:	VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description:	VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Overall Number of Participants Analyzed	47
Measure Type: Count of Participants Unit of Measure: Participants
Not refractory to diuretics	7 14.9%
Refractory to diuretics	40 85.1%

8.Secondary Outcome


Title	Percentage of Population in Which Clinical Decision Making Would Have Been Influenced by Adding FAST GFR and PV Measurements to Clinical Routine Determined by Survey Response (by an Adjudication Committee)
Description	Percentage of patients for whom the data decision committee decided to...
Description	Percentage of patients for whom the data decision committee decided to increase or decrease the dose of diuretics, guideline-directed medical therapy (GDMT), beta-blockers, or RAAS inhibitors from the dose indicated by the treating physician after considering the mPV/mTBV determined using FAST BioMedical technology.
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	All Patients
Arm/Group Description:	VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description:	VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
Overall Number of Participants Analyzed	50
Measure Type: Count of Participants Unit of Measure: Participants
Number or patients where adjudication committee would have changed diuretic dose	40 80.0%
Number or patients where adjudication committee would have changed RAASi dose	5 10.0%
Number or patients where adjudication committee would have changed beta blocker dose	6 12.0%
Number or patients where adjudication committee would have changed GDMT	1 2.0%

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	All Patients
Arm/Group Description	VFI dose: 47 mg / 3 mL Number of do...
Arm/Group Description	VFI dose: 47 mg / 3 mL Number of doses: 2 Route of administration: intravenous VFI: The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
All-Cause Mortality
	All Patients
	Affected / at Risk (%)
Total	1/50 (2.00%)
Serious Adverse Events Serious Adverse Events
	All Patients
	Affected / at Risk (%)
Total	21/50 (42.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	1/50 (2.00%)
Cardiac disorders
cardiac failure ^† 1	3/50 (6.00%)
Atrial fibrillation ^† 1	1/50 (2.00%)
Gastrointestinal disorders
Thrombosis mesenteric vessel ^† 1	1/50 (2.00%)
General disorders
Multiple organ dysfunction syndrome ^† 1	1/50 (2.00%)
Infections and infestations
Pneumonia ^† 1	3/50 (6.00%)
Endocarditis ^† 1	2/50 (4.00%)
Infectious pleural effusion ^† 1	1/50 (2.00%)
Urosepsis ^† 1	1/50 (2.00%)
Injury, poisoning and procedural complications
Anaemia postoperative ^† 1	1/50 (2.00%)
Lumbar vertebral fracture ^† 1	1/50 (2.00%)
Post procedural fistula ^† 1	1/50 (2.00%)
Post procedural haemorrhage ^† 1	1/50 (2.00%)
Postoperative delirium ^† 1	1/50 (2.00%)
Investigations
Troponin increased ^† 1	1/50 (2.00%)
Metabolism and nutrition disorders
Fluid overload ^† 1	1/50 (2.00%)
Nervous system disorders
Cerebral infarction ^† 1	1/50 (2.00%)
Syncope ^† 1	1/50 (2.00%)
Renal and urinary disorders
Acute kidney Injury ^† 1	3/50 (6.00%)
Azotaemia ^† 1	1/50 (2.00%)
Vascular disorders
Hypertensive crisis ^† 1	1/50 (2.00%)
Ischaemia ^† 1	1/50 (2.00%)
1 Term from vocabulary, MedDRA (Unspecified) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	All Patients
	Affected / at Risk (%)
Total	37/50 (74.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	1/50 (2.00%)
Splenomegaly ^† 1	1/50 (2.00%)
Cardiac disorders
Cardiac failure ^† 1	3/50 (6.00%)
Atrial fibrillation ^† 1	1/50 (2.00%)
Arrhythmia ^† 1	1/50 (2.00%)
Coronary artery disease ^† 1	1/50 (2.00%)
Tachycardia ^† 1	1/50 (2.00%)
Congenital, familial and genetic disorders
Phimosis ^† 1	1/50 (2.00%)
Ear and labyrinth disorders
Vertigo ^† 1	1/50 (2.00%)
Gastrointestinal disorders
Diarrhoea ^† 1	6/50 (12.00%)
Constipation ^† 1	2/50 (4.00%)
Nausea ^† 1	2/50 (4.00%)
Abdominal pain lower ^† 1	1/50 (2.00%)
Colitis ^† 1	1/50 (2.00%)
Duodenal ulcer ^† 1	1/50 (2.00%)
Erosive oesophagitis ^† 1	1/50 (2.00%)
Gastritis ^† 1	1/50 (2.00%)
Gastrointestinal angiodysplasia ^† 1	1/50 (2.00%)
Haemorrhoids ^† 1	1/50 (2.00%)
Intestinal polyp ^† 1	1/50 (2.00%)
Large intestine polyp ^† 1	1/50 (2.00%)
Melaena ^† 1	1/50 (2.00%)
Subileus ^† 1	1/50 (2.00%)
Thrombosis mesenteric vessel ^† 1	1/50 (2.00%)
Varices oesophageal ^† 1	1/50 (2.00%)
Vomiting ^† 1	1/50 (2.00%)
General disorders
Pyrexia ^† 1	3/50 (6.00%)
Chest pain ^† 1	1/50 (2.00%)
Asthenia ^† 1	1/50 (2.00%)
Fatigue ^† 1	1/50 (2.00%)
Gait disturbance ^† 1	1/50 (2.00%)
Multiple organ dysfunction syndrome ^† 1	1/50 (2.00%)
Pain ^† 1	1/50 (2.00%)
Xerosis ^† 1	1/50 (2.00%)
Hepatobiliary disorders
Cholelithiasis ^† 1	1/50 (2.00%)
Immune system disorders
Drug hypersensitivity ^† 1	2/50 (4.00%)
Hypersensitivity ^† 1	1/50 (2.00%)
Infections and infestations
Pneumonia ^† 1	6/50 (12.00%)
Endocarditis ^† 1	2/50 (4.00%)
Urinary tract infection ^† 1	2/50 (4.00%)
Device related infection ^† 1	1/50 (2.00%)
Gastroenteritis ^† 1	1/50 (2.00%)
Gastroenteritis rotavirus ^† 1	1/50 (2.00%)
Infectious pleural effusion ^† 1	1/50 (2.00%)
Nasopharyngitis ^† 1	1/50 (2.00%)
Oesophageal candidiasis ^† 1	1/50 (2.00%)
Upper respiratory tract infection ^† 1	1/50 (2.00%)
Urosepsis ^† 1	1/50 (2.00%)
Injury, poisoning and procedural complications
Fall ^† 1	3/50 (6.00%)
Anaemia postoperative ^† 1	1/50 (2.00%)
Lumbar vertebral fracture ^† 1	1/50 (2.00%)
Post procedural fever ^† 1	1/50 (2.00%)
Post procedural fistula ^† 1	1/50 (2.00%)
Post procedural haematuria ^† 1	1/50 (2.00%)
Post procedural haemorrhage ^† 1	1/50 (2.00%)
Postoperative delirium ^† 1	1/50 (2.00%)
Procedural pain ^† 1	1/50 (2.00%)
Wound ^† 1	1/50 (2.00%)
Investigations
Aspartate aminotransferase increased ^† 1	3/50 (6.00%)
Troponin increased ^† 1	2/50 (4.00%)
Bilirubin conjugated increased ^† 1	2/50 (4.00%)
C-reactive protein increased ^† 1	2/50 (4.00%)
Gamma-glutamyltransferase increased ^† 1	2/50 (4.00%)
Blood alkaline phosphatase increased ^† 1	1/50 (2.00%)
Blood bilirubin increased ^† 1	1/50 (2.00%)
Blood creatine phosphokinase abnormal ^† 1	1/50 (2.00%)
Blood creatinine increased ^† 1	1/50 (2.00%)
Brain natriuretic peptide increased ^† 1	1/50 (2.00%)
Procalcitonin abnormal ^† 1	1/50 (2.00%)
Procalcitonin increased ^† 1	1/50 (2.00%)
Metabolism and nutrition disorders
Hypokalaemia ^† 1	4/50 (8.00%)
Decreased appetite ^† 1	2/50 (4.00%)
Hyperkalaemia ^† 1	2/50 (4.00%)
Electrolyte imbalance ^† 1	1/50 (2.00%)
Fluid overload ^† 1	1/50 (2.00%)
Hyperglycaemia ^† 1	1/50 (2.00%)
Hypernatraemia ^† 1	1/50 (2.00%)
Hyperphosphataemia ^† 1	1/50 (2.00%)
Hypertriglyceridaemia ^† 1	1/50 (2.00%)
Hyperuricaemia ^† 1	1/50 (2.00%)
Hypoalbuminaemia ^† 1	1/50 (2.00%)
Hypoproteinaemia ^† 1	1/50 (2.00%)
Iron deficiency ^† 1	1/50 (2.00%)
Metabolic acidosis ^† 1	1/50 (2.00%)
Vitamin D deficiency ^† 1	1/50 (2.00%)
Musculoskeletal and connective tissue disorders
Back pain ^† 1	2/50 (4.00%)
Joint swelling ^† 1	2/50 (4.00%)
Muscle spasms ^† 1	2/50 (4.00%)
Muscular weakness ^† 1	1/50 (2.00%)
Musculoskeletal pain ^† 1	1/50 (2.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma ^† 1	1/50 (2.00%)
Lung neoplasm ^† 1	1/50 (2.00%)
Nervous system disorders
Syncope ^† 1	2/50 (4.00%)
Cerebral infarction ^† 1	1/50 (2.00%)
Dementia Alzheimer's type ^† 1	1/50 (2.00%)
Dizziness ^† 1	1/50 (2.00%)
Headache ^† 1	1/50 (2.00%)
Partial seizures ^† 1	1/50 (2.00%)
Psychiatric disorders
Sleep disorder ^† 1	5/50 (10.00%)
Delirium ^† 1	1/50 (2.00%)
Depressed mood ^† 1	1/50 (2.00%)
Disorientation ^† 1	1/50 (2.00%)
Renal and urinary disorders
Acute kidney injury ^† 1	5/50 (10.00%)
Azotaemia ^† 1	1/50 (2.00%)
End stage renal disease ^† 1	1/50 (2.00%)
Urinary tract obstruction ^† 1	1/50 (2.00%)
Reproductive system and breast disorders
Benign prostatic hyperplasia ^† 1	2/50 (4.00%)
Penile haemorrhage ^† 1	1/50 (2.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	3/50 (6.00%)
Cough ^† 1	1/50 (2.00%)
Diaphragmatic disorder ^† 1	1/50 (2.00%)
Epistaxis ^† 1	1/50 (2.00%)
Painful respiration ^† 1	1/50 (2.00%)
Pleural effusion ^† 1	1/50 (2.00%)
Skin and subcutaneous tissue disorders
Pruritus ^† 1	3/50 (6.00%)
Skin disorder ^† 1	1/50 (2.00%)
Social circumstances
Immobile ^† 1	1/50 (2.00%)
Surgical and medical procedures
Coronary arterial stent insertion ^† 1	1/50 (2.00%)
Vascular disorders
Hypotension ^† 1	2/50 (4.00%)
Hypertensive crisis ^† 1	1/50 (2.00%)
Ischaemia ^† 1	1/50 (2.00%)
Thrombophlebitis ^† 1	1/50 (2.00%)
1 Term from vocabulary, MedDRA (Unspecified) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Prof. Dr. med. Kai Schmidt-Ott
Organization:	Charité - Universitätsmedizin Berlin
Phone:	+4930450614671
EMail:	Kai.schmidt-ott@charite.de

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hinze C, Karaiskos N, Boltengagen A, Walentin K, Redo K, Himmerkus N, Bleich M, Potter SS, Potter AS, Eckardt KU, Kocks C, Rajewsky N, Schmidt-Ott KM. Kidney Single-cell Transcriptomes Predict Spatial Corticomedullary Gene Expression and Tissue Osmolality Gradients. J Am Soc Nephrol. 2021 Feb;32(2):291-306. doi: 10.1681/ASN.2020070930. Epub 2020 Nov 25.

Layout table for additonal information

Responsible Party:	Kai Schmidt-Ott, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT03808948
Other Study ID Numbers:	EmPaKt-CHF 2018-002638-18 ( EudraCT Number )
First Submitted:	January 8, 2019
First Posted:	January 18, 2019
Results First Submitted:	July 28, 2021
Results First Posted:	November 17, 2021
Last Update Posted:	November 17, 2021

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