Dose Finding Study to Treat High Phosphate Levels in the Blood.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02081534
First received: March 6, 2014
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period


Condition Intervention Phase
Hyperphosphatemia
Drug: AZD1722
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of AZD1722 to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in serum phosphate levels [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ] [ Designated as safety issue: No ]
    Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment


Secondary Outcome Measures:
  • The number of patients reaching S-phosphate goal [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ] [ Designated as safety issue: No ]
    Comparison of the effect of AZD1722 versus placebo on the number of patients reaching serum phosphate goal levels defined as < 5.5 mg/dl (1.78 mmol/L) during 4 weeks of treatment

  • Change from baseline in calcium x phosphorus product [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ] [ Designated as safety issue: No ]
    Change from baseline (end of wash out) in calcium x phosphorus product

  • Change from pre wash out in S-phosphate levels [ Time Frame: Pre wash out to end of treatment (Day 29) ] [ Designated as safety issue: No ]
    Comparison of the effect of AZD1722 versus pre wash out phosphate-lowering treatment, by comparing serum phosphate levels during AZD1722 treatment to pre wash out levels

  • Safety and tolerability of AZD1722 [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of AZD1722 as assessed by adverse event recording, vital signs, 12-lead electrocardiogram, physical examination, and safety laboratory monitoring

  • Dose response relationship [ Time Frame: End of wash out (pre randomization value) to end of treatment (Day 29) ] [ Designated as safety issue: No ]
    To characterize the dose response relationship of AZD1722 on serum phosphate levels


Estimated Enrollment: 375
Study Start Date: March 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 mg bid
1 mg AZD1722 bid
Drug: AZD1722
AZD1722, oral tablet
Experimental: 3 mg bid
3 mg AZD1722 bid
Drug: AZD1722
AZD1722, oral tablet
Experimental: 10 mg bid
10 mg AZD1722 bid
Drug: AZD1722
AZD1722, oral tablet
Experimental: 30 mg bid
30 mg AZD1722 bid
Drug: AZD1722
AZD1722, oral tablet
Experimental: 3 mg od
3 mg AZD1722 od
Drug: AZD1722
AZD1722, oral tablet
Experimental: 30 mg od
30 mg AZD1722 od
Drug: AZD1722
AZD1722, oral tablet
Placebo Comparator: Placebo
Placebo (double dummy technique)
Drug: Placebo
Placebo bid, double dummy technique

Detailed Description:

The study consists of a screening period of approximately 1 week, a wash out period of up to 3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period and a follow-up period of up to 2 weeks, during which patients are put back on their pre washout phosphate lowering medication.

The wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in s-phosphate levels.

There are 7 parallel treatment arms in the study with bid and od treatment regimens.

Laboratory efficacy endpoints and safety assessments will be evaluated at various times throughout the study.

The target population of the study is: male or female patients, above18 years of age with End Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a minimum of 3 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females and males aged ≥18 years
  2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months
  3. Prescribed and taking at least 3 doses of phosphate binder per day
  4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
  5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
  6. For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion Criteria:

  1. Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
  2. Serum parathyroid hormone >1200 pg/mL
  3. Significant metabolic acidosis
  4. Clinical signs of hypovolemia at randomization

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02081534

Contacts
Contact: Anna Maria Langkilde, MD, PhD +46 31 7065652 ClinicalTrialTransparency@astrazeneca.com
Contact: Tina Rydén-Bergsten +46 31 7762283 tina.ryden-bergsten@astrazeneca.com

  Show 43 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Geoffrey A Block, MD Denver Nephrology PC, Denver, CO 80230
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02081534     History of Changes
Other Study ID Numbers: D5613C00001
Study First Received: March 6, 2014
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Health Authority
Slovakia: Health Authority

Keywords provided by AstraZeneca:
S-phosphate, hyperphosphatemia, hemodialysis, ESRD

Additional relevant MeSH terms:
Kidney Failure, Chronic
Hyperphosphatemia
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 24, 2014