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

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ClinicalTrials.gov Identifier: NCT01847092
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ardelyx

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Type 2 Diabetes Mellitus Drug: AZD1722 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: AZD1722
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
Drug: AZD1722
Placebo Comparator: Placebo
Placebo capsule BID PO for 12 Weeks
Drug: Placebo
Placebo for AZD1722




Primary Outcome Measures :
  1. Changes in Urine Albumin to Creatinine Ratio (UACR) [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. PD on u-Na excretion, mean weekly stool consistency and stool frequency [ Time Frame: Baseline to Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847092


Locations
United States, Colorado
Creekside Endocrine Associates PC
Denver, Colorado, United States, 80209
Sponsors and Collaborators
Ardelyx
AstraZeneca

Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT01847092     History of Changes
Other Study ID Numbers: D5610C00001
First Posted: May 6, 2013    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by Ardelyx:
albuminuria

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Albuminuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms