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Clinical Trial Results:
Multicentric, parallel, controlled, randomized, single blind clinical evaluation of a new low sodium peritoneal dialysis solution on patients with hypertension treated with continous ambulatory or automated peritoneal dialysis.

Summary
EudraCT number	2007-005365-35
Trial protocol	SE DE FR DK GB
Global end of trial date	14 Oct 2014

Results information
Results version number	v1(current)
This version publication date	11 Mar 2022
First version publication date	11 Mar 2022
Other versions
Summary report(s)	Davies_PDI_2020_PDOne_Study

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

1449

ISRCTN number

US NCT number

NCT00794326

WHO universal trial number (UTN)

Sponsor organisation name

Fresenius Medical Care Deutschland GmbH

Sponsor organisation address

Else-Kröner-Straße 1, Bad Homburg, Germany, 61352

Public contact

Department Clinical Research, Fresenius Medical Care Deutschland GmbH, +49 61726095457, Saynab.Atiye@fmc-ag.com

Scientific contact

Department Clinical Research, Fresenius Medical Care Deutschland GmbH, +49 61726095457, Saynab.Atiye@fmc-ag.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

25 Apr 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

14 Oct 2014

Global end of trial reached?

Yes

Global end of trial date

14 Oct 2014

Was the trial ended prematurely?

Main objective of the trial

The trial was performed to investigate the effect of a once-daily dwell with a glucose-compensated low-Na solution in hypertensive peritoneal dialysis (PD) patients (Test product PDsol 12, an isotonic low Na solution (Na 112 mM, glucose concentration 2%, 340 mOsm/L); Reference product Selutrio 40, Na 133 mM, isotonic 1.5% glucose solution, 356 mOsm/L). The objective was to demonstrate superiority of the low-Na solution over a standard solution regarding the lowering of blood pressure (BP).

Protection of trial subjects

The treatment with PDsol 12 was safe and well tolerated when compared to standard treatment. The profile of TEAE findings was generally consistent with the PD population represented in this study (e.g. complications such as peritonitis which are common for subjects on PD therapy), the nature of the underlying disease, and the expected safety profile of PDsol 12.

Background therapy

Peritoneal dialysis

Evidence for comparator

Actual start date of recruitment

20 Oct 2008

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Sweden: 46

Country: Number of subjects enrolled

United Kingdom: 40

Country: Number of subjects enrolled

Denmark: 5

Country: Number of subjects enrolled

France: 34

Country: Number of subjects enrolled

Germany: 33

Worldwide total number of subjects

158

EEA total number of subjects

118

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The patients to be included in this clinical study are suffering from chronic renal failure and are treated with peritoneal dialysis. These patients shall meet the inclusion and exclusion criteria defined for this study. 158 CAPD/ APD eligible and randomized patients were recruited according to the statistical hypothesis.

Screening details

Run-in phase 4 weeks: The study will start with a run-in period (around 4-weeks) for both medical and practical reasons: if after inclusion visit a change is decided in PD dose 4 weeks is a reasonable duration to allow stabilization on new prescription.

Period 1 title

Run-in-phase

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Run-in-phase

Arm description

Run-in phase 4 weeks: The study will start with a run-in period (around 4-weeks) during which the patients’ eligibility for participation was confirmed. They were stabilised on their currently prescribed standard dialysis treatment regimen.

Arm type

Active comparator

Investigational medicinal product name

Selutrio 40

Investigational medicinal product code

Other name

Gambrosol Trio 40

Pharmaceutical forms

Intraperitoneal solution

Routes of administration

Intraperitoneal use

Dosage and administration details

1 daytime dwell time during 4 ± 1 hours

Number of subjects in period 1	Run-in-phase
Started	158
Completed	128
Not completed	30
not known	3
In-/ exclusion criteria not fulfilled	5
Ineligibility after ABPM results	3
No reason for termination documented	16
Patient PD treatment not stable	3

Period 2 title

Efficacy period - Safety analysis set

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Investigator ^[1]

Blinding implementation details

The study was single-blinded since the identity of study medication could be easily recognized by the investigator based on subjects’ laboratory data during the study. Both IMPs (i.e. test- and reference products) were manufactured to look the same and differed only by the name/code indicated on the label (i.e. PDsol 12/1 and PDsol 12/2).

Are arms mutually exclusive

Yes

PDsol 12 group

Arm description

1 bag PDsol 12 (1 daytime dwell time during 4 ± 1 hours) Treatment with study medication started on the day after visit T0 and lasted 6 months. The standard Na, isotonic glucose bag was to be replaced for one daytime dwell time during 4 ± 1 hours by PDsol 12 for subjects assigned to low Na treatment (i.e. PDsol 12 group).

Arm type

Experimental

Investigational medicinal product name

PDsol 12

Investigational medicinal product code

Other name

Pharmaceutical forms

Intraperitoneal solution

Routes of administration

Intraperitoneal use

Dosage and administration details

1 bag PDsol 12 (1 daytime dwell time during 4 ± 1 hours)

Selutrio 40 group

Arm description

1 bag Selutrio 40 (1 daytime dwell time during 4 ± 1 hours) Treatment with study medication started on the day after visit T0 and lasted 6 months. The standard Na, isotonic glucose bag was to be replaced for one daytime dwell time during 4 ± 1 hours by Selutrio 40 for subjects assigned to treatment with the reference product (Selutrio 40 group).

Arm type

Active comparator

Investigational medicinal product name

Selutrio 40

Investigational medicinal product code

Other name

Pharmaceutical forms

Intraperitoneal solution

Routes of administration

Intraperitoneal use

Dosage and administration details

1 daytime dwell time during 4 ± 1 hours

Notes
[1] - The roles blinded appear inconsistent with a simple blinded trial.
Justification: The study was single-blinded since the identity of study medication could be easily recognized by the investigator based on subjects’ laboratory data during the study.

Number of subjects in period 2	PDsol 12 group	Selutrio 40 group
Started	63	65
Completed	60	63
Not completed	3	2
Adverse event, non-fatal	3	2

Period 3 title

Safety period - Full analysis set (FAS)

Is this the baseline period?

Yes ^[2]

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Investigator ^[3]

Blinding implementation details

Are arms mutually exclusive

Yes

PDsol 12 group

Arm description

Arm type

Experimental

Investigational medicinal product name

PDsol 12

Investigational medicinal product code

Other name

Pharmaceutical forms

Intraperitoneal solution

Routes of administration

Intraperitoneal use

Dosage and administration details

1 bag PDsol 12 (1 daytime dwell time during 4 ± 1 hours)

Selutrio 40 group

Arm description

1 bag Solutio 40 (1 daytime dwell time during 4 ± 1 hours) Treatment with study medication started on the day after visit T0 and lasted 6 months. The standard Na, isotonic glucose bag was to be replaced for one daytime dwell time during 4 ± 1 hours by Selutrio 40 for subjects assigned to treatment with the reference product (Selutrio 40 group).

Arm type

Active comparator

Investigational medicinal product name

Selutrio 40

Investigational medicinal product code

Other name

Pharmaceutical forms

Intraperitoneal solution

Routes of administration

Intraperitoneal use

Dosage and administration details

1 daytime dwell time during 4 ± 1 hours

Notes
[2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
Justification: The presentation of baseline characteristics are based on the Full Analysis Set. The Full Analysis Set (FAS) will consist of all randomized patients after a four-week run-in period.
[3] - The roles blinded appear inconsistent with a simple blinded trial.
Justification: The study was single-blinded since the identity of study medication could be easily recognized by the investigator based on subjects’ laboratory data during the study.

Number of subjects in period 3 ^[4]	PDsol 12 group	Selutrio 40 group
Started	60	63
Completed	45	43
Not completed	15	20
Transfer to hemodialysis	2	2
Adverse event, serious fatal	-	1
Consent withdrawn by subject	1	4
• Stop of PD for 6 weeks due to hernia repair	1	-
Adverse event, non-fatal	5	6
Kidney/renal transplantation	1	3
Poor compliance	-	1
Atrial fibrillation	-	1
Adequate PD therapy was no longer possible	1	-
Patient condition no longer requires trial	4	-
subject’s condition no longer required study treat	-	2

Notes
[4] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: All baseline characteristics were analyzed for the Full analysis set (FAS). All 123 subjects who attended T0 and received at least one bag of study medication were included in the FAS.

Period 4 title

Follow up period

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Follow up

Arm description

Follow up for 2 months after completion of study treatment according to site routine (for all subjects to monitor BP and antihypertensive and/or diuretic medication after stopping the use of study medication and enable control of possible BP increase).

Arm type

Active comparator

Investigational medicinal product name

PDsol 12

Investigational medicinal product code

Other name

Pharmaceutical forms

Intraperitoneal solution

Routes of administration

Intraperitoneal use

Dosage and administration details

1 bag PDsol 12 (1 daytime dwell time during 4 ± 1 hours)

Number of subjects in period 4	Follow up
Started	88
Completed	88

Baseline characteristics

Top of page

Reporting group title

PDsol 12 group

Reporting group description

Reporting group title

Selutrio 40 group

Reporting group description

Reporting group values	PDsol 12 group	Selutrio 40 group	Total
Number of subjects	60	63	123
Age categorical
Units: Subjects
Adults 18 years and more	60	63	123
Age continuous
Units: years
median (full range (min-max))	61.0 (31 to 84)	55.0 (23 to 83)	-
Gender categorical
Units: Subjects
Female	14	18	32
Male	46	45	91
Dry weight
Units: kg
median (full range (min-max))	81.8 (42 to 128)	76.7 (42 to 102)	-
Height
Units: cm
median (full range (min-max))	174.0 (150 to 190)	172.0 (152 to 186)	-
Residual renal function
Units: mL/min/1.73 m2
arithmetic mean (standard deviation)	5.0 ( 3.27 )	4.9 ( 3.61 )	-
24-h Total creatinine clearance
Units: mL/min/1.73 m2
arithmetic mean (standard deviation)	13.2 ( 15.5 )	7.9 ( 6.6 )	-
Total weekly Kt/V
parameter for dialysis adequacy
Units: no unit
arithmetic mean (standard deviation)	2.3 ( 0.62 )	2.3 ( 0.53 )	-

End points

Top of page

Reporting group title

Run-in-phase

Reporting group description

Reporting group title

PDsol 12 group

Reporting group description

Reporting group title

Selutrio 40 group

Reporting group description

Reporting group title

PDsol 12 group

Reporting group description

Reporting group title

Selutrio 40 group

Reporting group description

Reporting group title

Follow up

Reporting group description

Primary: Responder rate

Top of page

End point title

Responder rate

End point description

Responders are defined as having experienced at least one of the following response criteria: a. Improvement of arterial hypertension by a decrease of 6 mmHg or more on the mean 24h SBP, measured from ABPM (T2-Baseline) in patients without antihypertensive medication modification. b. Documented occurrence of hypotension requiring a medical action (decrease of antihypertensive drug medication) during the efficacy period (visit T0 through T2) confirmed by the DSMB. The primary endpoint will be analysed with the Cochran-Mantel-Haenszel test stratified for the 24h AMBP SBP stratification variable. Superiority of the new formulation over standard-Na solution could not be confirmed statistically (p = 0.512). Our sensitivity analysis in which patients with missing response data were counted as either responders or nonresponders, as well as the analysis in the PPS (p = 0.296), led to the same conclusion.

End point type

Primary

End point timeframe

study phase Mean 24h SBP will be calculated as the arithmetic mean value of all available observations for the 24h observation period.

End point values	PDsol 12 group	Selutrio 40 group
Number of subjects analysed	60	63
Units: numbers
Subjets with valid data	58	55
Total responders	20	16
Response defined by (a) Mean 24-h systolic blood p	11	16
Response defined by (b) Fall in blood pressure req	9	0

Primary endpoint

Comparison groups

Selutrio 40 group v PDsol 12 group

Number of subjects included in analysis

123

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.05

Method

Cochran-Mantel-Haenszel

Confidence interval

Secondary: Serial BP measurements during the 8-week efficacy period

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End point title

Serial BP measurements during the 8-week efficacy period

End point description

Secondary outcomes for Blood pressure (BP) included 24-h ABPM of daytime and night-time SBP and DBP and office BP measurements

End point type

Secondary

End point timeframe

Serial BP measurements during the 8-week efficacy period (Full analysis set (FAS))

End point values	PDsol 12 group	Selutrio 40 group
Number of subjects analysed	60 ^[1]	63 ^[2]
Units: mmHg
arithmetic mean (standard deviation)
24-h ABPM SBP (mmHg)	-2.3 ( 15.9 )	-1.2 ( 14.5 )
24-h ABMP DBP (mmHg)	-1.0 ( 10.3 )	-1.0 ( 8.6 )
24-h ABPM SBP (mmHg) day	-1.9 ( 15.5 )	-1.7 ( 15.1 )
24-h ABMP DBP (mmHg) day	-0.7 ( 10.4 )	-1.3 ( 9.4 )
24-h ABPM SBP (mmHg) night	-3.5 ( 16.1 )	0.6 ( 15.0 )
24-h ABMP DBP (mmHg) night	-2.1 ( 11.2 )	0.3 ( 7.9 )
Office SBP (mmHg	-5.0 ( 16.7 )	-3.3 ( 15.9 )
Office DBP (mmHg	-1.8 ( 8.7 )	-0.6 ( 12.8 )
Self-measured SBP (mmHg)	-5.6 ( 14.6 )	3.6 ( 13.3 )
Self-measured DBP (mmHg)	-3.2 ( 8.3 )	1.7 ( 9.4 )

Notes
[1] - Full analysis set (FAS)
[2] - Full analysis set (FAS)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

AEs were analyzed in safety analysis set (SAF) timeframe 6 months

Adverse event reporting additional description

- Listening of most frequently reported treatment-emergent AEs (occurrence in ≥3% of subjects in total) from beginning of study treatment to end of study by SOC and PT (SAF) - Listing of treatment-emergent SAEs (occurrence in ≥2 subjects in either treatment group) by SOC and PT (SAF) TEAE or serious TEAE (TESAE) were defined as any AE or SAE.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.0

Reporting group title

Safety analysis set

Reporting group description

The safety analysis set will consist of all randomized subjects that received any amount of study medication.

Reporting group title

PDsol 12

Reporting group description

Reporting group title

Selutrio 40

Reporting group description

Serious adverse events	Safety analysis set	PDsol 12	Selutrio 40
Total subjects affected by serious adverse events
subjects affected / exposed	35 / 128 (27.34%)	16 / 63 (25.40%)	19 / 65 (29.23%)
number of deaths (all causes)	2	1	1
number of deaths resulting from adverse events	2	1	1
Vascular disorders
Hypotension
subjects affected / exposed	3 / 128 (2.34%)	3 / 63 (4.76%)	0 / 65 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
General disorders and administration site conditions
subjects affected / exposed	4 / 128 (3.13%)	1 / 63 (1.59%)	3 / 65 (4.62%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sudden death
subjects affected / exposed	1 / 128 (0.78%)	0 / 63 (0.00%)	1 / 65 (1.54%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	2 / 128 (1.56%)	0 / 63 (0.00%)	2 / 65 (3.08%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 12
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
subjects affected / exposed	3 / 128 (2.34%)	0 / 63 (0.00%)	3 / 65 (4.62%)
occurrences causally related to treatment / all	0 / 3	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Peritonitis
subjects affected / exposed	8 / 128 (6.25%)	4 / 63 (6.35%)	4 / 65 (6.15%)
occurrences causally related to treatment / all	0 / 8	0 / 4	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonitis bacterial
subjects affected / exposed	3 / 128 (2.34%)	1 / 63 (1.59%)	2 / 65 (3.08%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Septic shock
subjects affected / exposed	1 / 128 (0.78%)	1 / 63 (1.59%)	0 / 65 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Metabolism and nutrition disorders
Metabolism and nutrition disorders
subjects affected / exposed	3 / 128 (2.34%)	1 / 63 (1.59%)	2 / 65 (3.08%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	Safety analysis set	PDsol 12	Selutrio 40
Total subjects affected by non serious adverse events
subjects affected / exposed	114 / 128 (89.06%)	50 / 63 (79.37%)	49 / 65 (75.38%)
Vascular disorders
Hypotension
subjects affected / exposed	28 / 128 (21.88%)	17 / 63 (26.98%)	11 / 65 (16.92%)
occurrences all number	28	17	11
Hypertension
subjects affected / exposed	10 / 128 (7.81%)	4 / 63 (6.35%)	6 / 65 (9.23%)
occurrences all number	10	4	6
General disorders and administration site conditions
Oedema peripheral
subjects affected / exposed	8 / 128 (6.25%)	2 / 63 (3.17%)	6 / 65 (9.23%)
occurrences all number	8	2	6
Asthenia
subjects affected / exposed	2 / 128 (1.56%)	2 / 63 (3.17%)	0 / 65 (0.00%)
occurrences all number	2	2	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	5 / 128 (3.91%)	0 / 63 (0.00%)	5 / 65 (7.69%)
occurrences all number	5	0	5
Investigations
Investigations
subjects affected / exposed	5 / 128 (3.91%)	2 / 63 (3.17%)	3 / 65 (4.62%)
occurrences all number	5	2	4
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
subjects affected / exposed	4 / 128 (3.13%)	2 / 63 (3.17%)	2 / 65 (3.08%)
occurrences all number	4	2	2
Nervous system disorders
Dizziness
subjects affected / exposed	10 / 128 (7.81%)	7 / 63 (11.11%)	3 / 65 (4.62%)
occurrences all number	10	7	3
Headache
subjects affected / exposed	5 / 128 (3.91%)	2 / 63 (3.17%)	3 / 65 (4.62%)
occurrences all number	5	2	3
Ear and labyrinth disorders
Ear and labyrinth disorders
subjects affected / exposed	4 / 128 (3.13%)	1 / 63 (1.59%)	3 / 65 (4.62%)
occurrences all number	4	1	3
Gastrointestinal disorders
Vomiting
subjects affected / exposed	7 / 128 (5.47%)	1 / 63 (1.59%)	6 / 65 (9.23%)
occurrences all number	7	1	6
Diarrhoea
subjects affected / exposed	4 / 128 (3.13%)	1 / 63 (1.59%)	3 / 65 (4.62%)
occurrences all number	4	1	3
Abdominal pain
subjects affected / exposed	5 / 128 (3.91%)	1 / 63 (1.59%)	4 / 65 (6.15%)
occurrences all number	5	1	4
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
subjects affected / exposed	8 / 128 (6.25%)	7 / 63 (11.11%)	1 / 65 (1.54%)
occurrences all number	8	7	1
Renal and urinary disorders
Renal and urinary disorders
subjects affected / exposed	4 / 128 (3.13%)	2 / 63 (3.17%)	2 / 65 (3.08%)
occurrences all number	4	2	2
Endocrine disorders
Endocrine disorders
subjects affected / exposed	4 / 128 (3.13%)	2 / 63 (3.17%)	2 / 65 (3.08%)
occurrences all number	4	2	2
Musculoskeletal and connective tissue disorders
Muscle spasms
subjects affected / exposed	4 / 128 (3.13%)	3 / 63 (4.76%)	1 / 65 (1.54%)
occurrences all number	4	3	1
Infections and infestations
Peritonitis
subjects affected / exposed	17 / 128 (13.28%)	8 / 63 (12.70%)	9 / 65 (13.85%)
occurrences all number	25	9	12
Bronchitis
subjects affected / exposed	5 / 128 (3.91%)	3 / 63 (4.76%)	2 / 65 (3.08%)
occurrences all number	5	3	2
Peritonitis bacterial
subjects affected / exposed	3 / 128 (2.34%)	1 / 63 (1.59%)	2 / 65 (3.08%)
occurrences all number	3	1	2
Metabolism and nutrition disorders
Hyperkalaemia
subjects affected / exposed	4 / 128 (3.13%)	2 / 63 (3.17%)	2 / 65 (3.08%)
occurrences all number	4	2	2
Hyponatraemia
subjects affected / exposed	4 / 128 (3.13%)	3 / 63 (4.76%)	1 / 65 (1.54%)
occurrences all number	4	3	1

More information

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Were there any global substantial amendments to the protocol? Yes

16 Jun 2009

1st amendment of CSP version 3.0: • Modification/ Deletion of exclusion criteria

24 Jun 2009

2nd amendment of CSP version 3.0: implemented in the amended CSP version 4.0 • Study flowchart was included as an integrated part of the amended protocol • Corrections in the statistical section of the protocol

22 Oct 2009

The 3rd amendment of CSP version 3.0: implemented in the amended CSP version 5.0 • Change in sponsor’s name and address due to acquisition of the PD business of Gambro AB by the Fresenius Medical Care Deutschland GmbH, dated 27-DEC-2010 • Prolongation of study duration until December 2013 • Modification of one inclusion criterion and one exclusion criterion

04 Jun 2012

1st amendment of CSP version 6.0: • Deletion of one exclusion criterion

05 Dec 2013

2nd amendment of CSP version 6.0: • Prolongation of recruitment until 31-DEC-2014 • Update of study site number and countries (UK was added) • Replacement of the IMP name “Gambrosol trio 40” with the new name “Gambrosol trio 40/Selutrio 40” given the planned removal of "Gambro" from all product names as of Q1/2014

22 Aug 2014

3rd amendment of CSP version 6.0: • Correction of primary objective • Change in one secondary efficacy variable • Clarification of DSMB function and responsibilities • Involvement of a CRO for data entry/data management processes

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/32425111

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Clinical trials

Clinical Trial Results:
Multicentric, parallel, controlled, randomized, single blind clinical evaluation of a new low sodium peritoneal dialysis solution on patients with hypertension treated with continous ambulatory or automated peritoneal dialysis.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Responder rate

Primary: Responder rate

Secondary: Serial BP measurements during the 8-week efficacy period

Secondary: Serial BP measurements during the 8-week efficacy period

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

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Clinical trials

Clinical Trial Results: Multicentric, parallel, controlled, randomized, single blind clinical evaluation of a new low sodium peritoneal dialysis solution on patients with hypertension treated with continous ambulatory or automated peritoneal dialysis.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Responder rate

Primary: Responder rate

Secondary: Serial BP measurements during the 8-week efficacy period

Secondary: Serial BP measurements during the 8-week efficacy period

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
Multicentric, parallel, controlled, randomized, single blind clinical evaluation of a new low sodium peritoneal dialysis solution on patients with hypertension treated with continous ambulatory or automated peritoneal dialysis.