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Trial record 52 of 119 for:    ZIRCONIUM

The Effect of Sodium Zirconium Cyclosilicate on Albuminuria in Patients With Type 2 Diabetes and Hyperkalemia (ZIRCUS)

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ClinicalTrials.gov Identifier: NCT04063930
Recruitment Status : Not yet recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
AstraZeneca
Zealand University Hospital
Information provided by (Responsible Party):
Steno Diabetes Center Copenhagen

Brief Summary:
To investigate whether concomitant treatment with Lokelma can improve the efficacy of standard blockade of the renin-angiotensin system in patients with type 2 diabetes, diabetic nephropathy and hyperkalemia.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus With Kidney Complications Drug: LOKELMA 5 GM Powder for Oral Suspension Drug: Placebos Phase 4

Detailed Description:

Patients with type 2 diabetes and nephropathy, especially patients with impaired kidney function, frequently encounter hyperkalemia as an adverse effect of RAAS blocking treatment. Consequently, RAAS blocking treatment is reduced or discontinued, which in turn impairs prognosis in terms of long-term renal and cardiovascular outcome. Not only can hyperkalemia as an adverse event lead to changes in RAAS blocking treatment, the presence of persistent potassium levels in the upper part of the normal range can impair the efficacy of the RAAS blocking treatment, another reason to expect a beneficial effect of Lokelma treatment.

The study is a multicentre (3 sites in Sweden (TBD), 2 sites in Denmark (Steno Diabetes Center Copenhagen and Zealand University Hospital, Roskilde), double-blind, randomized placebo-controlled, parallel study. The study drug is compared to matching placebo that cannot be distinguished from active drug. The treatment period is 12 weeks.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Parallel, Multicenter Study of the Effects of 12-weeks of Sodium Zirconium Cyclosilicate (Lokelma) on Albuminuria (UACR) in Patients With Type 2 Diabetes and Hyperkalemia
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Active Comparator: Lokelma

Sodium zirconium cyclosilicate Lokelma® 5 g, powder (Astra Zeneca)

After initial dosing subjects will be instructed to take the study drug once daily in the morning, by oral administration after the powder has been dissolved in a glass of drinking water.

Duration: 12 weeks

Drug: LOKELMA 5 GM Powder for Oral Suspension
Sodium zirconium cyclosilicate (a hyperkalemia treatment)

Placebo Comparator: Placebo

Matching placebo (indistinguishable from the active comparator)

After initial dosing subjects will be instructed to take the study drug once daily in the morning, by oral administration after the powder has been dissolved in a glass of drinking water.

Duration: 12 weeks

Drug: Placebos
Matching placebo




Primary Outcome Measures :
  1. Urinary albumin creatinine ratio (UACR) [ Time Frame: 12 weeks ]
    Change in the geometric mean of UACR (milligram per gram) measured in three consecutive morning spot urine collections from baseline to end of treatment


Secondary Outcome Measures :
  1. Estimated glomerular filtration rate (eGFR) [ Time Frame: 12 weeks ]
    Change in eGFR mL/min/1.73 m2 (CKD-EPI formula) from baseline to end of treatment

  2. Urinary sodium [ Time Frame: 12 weeks ]
    Change in urinary sodium levels (mmol per liter) in one 24h urine collection from baseline to end of treatment period

  3. Urinary potassium [ Time Frame: 12 weeks ]
    Change in urinary potassium levels (mmol per liter) in one 24h urine collection from baseline to end of treatment period


Other Outcome Measures:
  1. Safety outcome - Adverse events [ Time Frame: 12 weeks ]
    Total number of adverse events from baseline to end of treatment

  2. Safety outcome - Electrocardiogram [ Time Frame: 12 weeks ]
    Number of adverse events related to changes in the electrocardiogram (e.g. QTc prolongation) from baseline to end of treatment



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female and/or male patients with type 2 diabetes aged 18-85 years
  3. Persistent macroalbuminuria (UACR ≥ 200 mg/g in at least two out of the three latest UACR measurements in subject history).
  4. Chronic (at least 1 month) stable RAAS blocking treatment, i.e maximum tolerated (individually defined by investigator) dose of an ACE inhibitor or ARB at time of inclusion.
  5. Documented hyperkalemia (plasma potassium ≥ 5.0 mmol/l) at least once in the 90 days prior to inclusion in the study.
  6. Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
  7. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of Lokelma/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.

Exclusion Criteria:

  1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
  2. Previous enrolment in the present study
  3. Use of potassium-lowering agent (loop-diuretics not included)
  4. Participation in another clinical study with an investigational product during the last 3 months prior to inclusion.
  5. Plasma potassium < 3.5 mmol/l within the previous six months before inclusion.
  6. Known hypersensitivity to Lokelma
  7. Known history of drug or alcohol abuse within 1 year of screening
  8. Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73 m2 (calculated by CKD-EPI formula).
  9. History of long QT syndrome.
  10. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.

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): NCT04063930


Contacts
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Contact: Peter Rossing, Professor 0045 30913383 peter.rossing@regionh.dk

Locations
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Denmark
Steno Diabetes Center Copenhagen
Gentofte, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
AstraZeneca
Zealand University Hospital

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Responsible Party: Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT04063930     History of Changes
Other Study ID Numbers: 2019-000595-42
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Steno Diabetes Center Copenhagen:
Hyperkalemia
Renin angiotensin system
Additional relevant MeSH terms:
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Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperkalemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Water-Electrolyte Imbalance