Phase 2 N=154 Randomized Quadruple-blind Treatment

A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

Chronic Kidney Disease · Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT01847092 ↗

Enrolled (actual)

154

Serious AEs

3.3%

Results posted

May 2020

Primary outcome: Primary: Changes in Urine Albumin to Creatinine Ratio (UACR) — -64.6; 104.8 mg/g — p=0.279

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AZD1722 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ardelyx
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Urine Albumin to Creatinine Ratio (UACR)	-64.6; 104.8	0.279
SECONDARY Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint	-2.8; -2.7	0.94

Summary

The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.

Eligibility Criteria

Inclusion Criteria

Males or females aged 18 to 80 years, inclusive.
Body mass index between 18 and 45 kg/m2, inclusive.
Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization
Stage 3 CKD
MSSBP ≥130 mmHg
Urinary albumin: mean UACR ≥ 200 mg/g

Exclusion Criteria

Urinary albumin: UACR > 3500 mg/g
History of a renal transplant
MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in periods
History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01847092). 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.