Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Ardelyx
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ardelyx
ClinicalTrials.gov Identifier:
NCT01847092
First received: May 2, 2013
Last updated: January 24, 2014
Last verified: January 2014

May 2, 2013
January 24, 2014
May 2013
December 2014   (final data collection date for primary outcome measure)
Changes in Urine Albumin to Creatinine Ratio (UACR) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01847092 on ClinicalTrials.gov Archive Site
PD effect on UACR, eGFR, blood pressure, p-NT-proBNP, s-cardiac troponin, u-aldosterone, p-renin activity, and bioimpedance [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
Same as current
PD on u-Na excretion, mean weekly stool consistency and stool frequency [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
Same as current
 
A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
An Exploratory Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD1722 in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Type 2 Diabetes Mellitus
  • Drug: AZD1722
  • Drug: Placebo
    Placebo for AZD1722
  • Active Comparator: AZD1722
    AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
    Intervention: Drug: AZD1722
  • Placebo Comparator: Placebo
    Placebo capsule BID PO for 12 Weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Susan Edelstein, PhD sedelstein@ardelyx.com
Contact: Lori Marshall, MPH lmarshall@ardelyx.com
United States
 
NCT01847092
D5610C00001
No
Ardelyx
Ardelyx
AstraZeneca
Not Provided
Ardelyx
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP