Trial Outcomes & Findings for ARIA (Atacand Renoprotection In NephropAthy Pt.) (NCT NCT00573430)

Results Overview

Decrease of urinary protein/creatinine ratio means improvement of renal disease.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

128 participants

Primary outcome timeframe

baseline to 28 weeks

Results posted on

2011-08-23

Participant Flow

155 enrolled, 27 screening failure, 128 randomized. Eligibility criteria not fulfilled meant subjects who were not fulfilled at Visit 1 or Enrolment, but screening failure subjects were who fulfilled at Visit 1, but not at Visit 2 after screening period.

Total 128 patient enrolled, but among of them, 9 subjects excluded from analysis because of Withdrawal by Subject, Protocol violation, Eligibility criteria not fullfiled. You can see these number in above table. This analysis was conducted based on Intend to treat. Therefore, total analyzed number is 119, and 39, 44, 36 per arm respectively.

Participant milestones

Participant milestones
Measure	Candesartan 8 mg Candesartan 8 mg oral once daily dose	Candesartan 16mg Candesartan 16mg oral once daily dose	Candesartan 32mg Candesartan 32mg oral once daily dose
Overall Study STARTED	40	45	43
Overall Study COMPLETED	39	40	33
Overall Study NOT COMPLETED	1	5	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Candesartan 8 mg Candesartan 8 mg oral once daily dose	Candesartan 16mg Candesartan 16mg oral once daily dose	Candesartan 32mg Candesartan 32mg oral once daily dose
Overall Study Incorrect enrollment of randomization	0	4	3
Overall Study Adverse Event	0	0	2
Overall Study Withdrawal by Subject	1	0	1
Overall Study Protocol Violation	0	1	1
Overall Study Eligibility criteria not fulfilled	0	0	3

Baseline Characteristics

ARIA (Atacand Renoprotection In NephropAthy Pt.)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Candesartan 8 mg n=40 Participants Candesartan 8 mg oral once daily dose	Candesartan 16mg n=45 Participants Candesartan 16mg oral once daily dose	Candesartan 32mg n=43 Participants Candesartan 32mg oral once daily dose	Total n=128 Participants Total of all reporting groups
Age Continuous 19 to 70	45.70 years STANDARD_DEVIATION 11 • n=93 Participants	46.80 years STANDARD_DEVIATION 16 • n=4 Participants	49.50 years STANDARD_DEVIATION 11 • n=27 Participants	47.3 years STANDARD_DEVIATION 13.4 • n=483 Participants
Gender Female	20 Participants n=93 Participants	16 Participants n=4 Participants	17 Participants n=27 Participants	53 Participants n=483 Participants
Gender Male	19 Participants n=93 Participants	28 Participants n=4 Participants	19 Participants n=27 Participants	66 Participants n=483 Participants

PRIMARY outcome

Timeframe: baseline to 28 weeks

Decrease of urinary protein/creatinine ratio means improvement of renal disease.

Outcome measures

Outcome measures
Measure	Candesartan 8 mg n=39 Participants Candesartan 8 mg oral once daily dose	Candesartan 16mg n=44 Participants Candesartan 16mg oral once daily dose	Candesartan 32mg n=36 Participants Candesartan 32mg oral once daily dose
The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks	794.0 mg/g Standard Deviation 1,070.10	639.9 mg/g Standard Deviation 863.30	819.0 mg/g Standard Deviation 823.60

SECONDARY outcome

Timeframe: baseline to 28 weeks

Outcome measures

Outcome measures
Measure	Candesartan 8 mg n=39 Participants Candesartan 8 mg oral once daily dose	Candesartan 16mg n=44 Participants Candesartan 16mg oral once daily dose	Candesartan 32mg n=36 Participants Candesartan 32mg oral once daily dose
Change of Systolic and Diastolic Blood Pressure From Baseline Systolic	-11.70 mmHg Standard Deviation 14.90	-13.30 mmHg Standard Deviation 14.90	-16.10 mmHg Standard Deviation 17.30
Change of Systolic and Diastolic Blood Pressure From Baseline Diastolic	-8.90 mmHg Standard Deviation 13.30	-8.00 mmHg Standard Deviation 13.30	-13.00 mmHg Standard Deviation 14.70

SECONDARY outcome

Timeframe: baseline to 28 weeks

To evaluate how to reduce and relate with cardiovascular risk

Outcome measures

Outcome measures
Measure	Candesartan 8 mg n=38 Participants Candesartan 8 mg oral once daily dose	Candesartan 16mg n=41 Participants Candesartan 16mg oral once daily dose	Candesartan 32mg n=35 Participants Candesartan 32mg oral once daily dose
Inflammatory Marker (Hs-C-peptide Reactive Protein)	0.01 mg/dL Standard Deviation 0.12	-0.17 mg/dL Standard Deviation 1.86	-0.01 mg/dL Standard Deviation 0.38

SECONDARY outcome

Timeframe: 28 weeks

GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units)

Outcome measures

Outcome measures
Measure	Candesartan 8 mg n=39 Participants Candesartan 8 mg oral once daily dose	Candesartan 16mg n=44 Participants Candesartan 16mg oral once daily dose	Candesartan 32mg n=36 Participants Candesartan 32mg oral once daily dose
Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation	1.28 mL/min/1.73 m2 Standard Deviation 8.45	1.20 mL/min/1.73 m2 Standard Deviation 9.31	0.56 mL/min/1.73 m2 Standard Deviation 8.92

SECONDARY outcome

Timeframe: Baseline to 28 weeks

Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product.

Outcome measures

Outcome measures
Measure	Candesartan 8 mg n=40 Participants Candesartan 8 mg oral once daily dose	Candesartan 16mg n=43 Participants Candesartan 16mg oral once daily dose	Candesartan 32mg n=47 Participants Candesartan 32mg oral once daily dose
Treatment-emergent Adverse Events	28 Participants	27 Participants	25 Participants

Adverse Events

Candesartan 8 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Candesartan 16mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Candesartan 32mg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Candesartan 8 mg n=40 participants at risk Candesartan 8 mg oral once daily dose	Candesartan 16mg n=45 participants at risk Candesartan 16mg oral once daily dose	Candesartan 32mg n=43 participants at risk Candesartan 32mg oral once daily dose
Nervous system disorders dizziness	0.00% 0/40	2.2% 1/45	0.00% 0/43
Blood and lymphatic system disorders Acute leukaemia	0.00% 0/40	0.00% 0/45	2.3% 1/43
Infections and infestations Pnuemonia	0.00% 0/40	0.00% 0/45	2.3% 1/43

Other adverse events

Other adverse events
Measure	Candesartan 8 mg n=40 participants at risk Candesartan 8 mg oral once daily dose	Candesartan 16mg n=45 participants at risk Candesartan 16mg oral once daily dose	Candesartan 32mg n=43 participants at risk Candesartan 32mg oral once daily dose
Infections and infestations Nasopharyngitis	10.0% 4/40	4.4% 2/45	11.6% 5/43
Nervous system disorders Dizziness	5.0% 2/40	4.4% 2/45	7.0% 3/43
Nervous system disorders Headache	5.0% 2/40	4.4% 2/45	0.00% 0/43
Respiratory, thoracic and mediastinal disorders Cough	7.5% 3/40	0.00% 0/45	2.3% 1/43

Additional Information

Gerard Lynch

AstraZeneca

Phone: +44 7780 956181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60