We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01847092
First Posted: May 6, 2013
Last Update Posted: September 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ardelyx
May 2, 2013
May 6, 2013
September 22, 2015
May 2013
March 2015   (Final data collection date for primary outcome measure)
Changes in Urine Albumin to Creatinine Ratio (UACR) [ Time Frame: Baseline to Week 12 ]
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 ]
Same as current
PD on u-Na excretion, mean weekly stool consistency and stool frequency [ Time Frame: Baseline to Week 12 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Completed
154
April 2015
March 2015   (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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01847092
D5610C00001
No
Not Provided
Not Provided
Ardelyx
Ardelyx
AstraZeneca
Not Provided
Ardelyx
September 2015

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