Phase 4
N=128
ARIA (Atacand Renoprotection In NephropAthy Pt.)
Non-diabetic Nephropathy With Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00573430 ↗Enrolled (actual)
128
Serious AEs
1.6%
Results posted
Jul 2011
Primary outcome: Primary: The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks — 794.0; 639.9; 819.0 mg/g
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Candesartan Cilexetil (Drug); Candesartan Cilexetil 32mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks |
794.0; 639.9; 819.0 | — |
| SECONDARY Change of Systolic and Diastolic Blood Pressure From Baseline |
-11.70; -13.30; -16.10; -8.90; -8.00; -13.00 | — |
| SECONDARY Inflammatory Marker (Hs-C-peptide Reactive Protein) |
0.01; -0.17; -0.01 | — |
| SECONDARY Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation |
1.28; 1.20; 0.56 | — |
| SECONDARY Treatment-emergent Adverse Events |
28; 27; 25 | — |
Summary
To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment
Eligibility Criteria
Inclusion Criteria
- hypertension; a)135mmHg 265 mmol/L (>3 mg/dL).
- Current serum-potassium > 5.5 mmol/L
- Known hypersensitivity to angiotensin (AT)1-receptor blocker
Data sourced from ClinicalTrials.gov (NCT00573430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.