Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria

Back to results

Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

potassium citrate

potassium phosphate

About this trial

This is an interventional treatment trial for Hypercalciuria focused on measuring hypercalciuria, nephrolithiasis, rare disease, renal and genitourinary disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Absorptive hypercalciuria Intestinal hyperabsorption of calcium, i.e.: Exaggerated calciuric response to oral calcium load OR Fractional calcium-47 absorption greater than 0.61 Calciuria greater than 200 mg/day on random and calcium-restricted diet Normal or high fasting urinary calcium Normal serum calcium Normal serum parathyroid hormone No primary hyperparathyroidism At least 1 calcium oxalate stone within the past 3 years No struvite or carbonate apatite stones No noncalcareous stones No numerous stones making precise quantitation difficult No renal tubular acidosis --Prior/Concurrent Therapy-- No concurrent drug therapy for nephrolithiasis --Patient Characteristics-- Creatinine clearance at least 0.7 mL/min per kilogram No hyperkalemia No hyperphosphatemia No urinary tract infection Other: No predisposition to hyperkalemia, including concurrent use of the following drugs: Potassium-sparing diuretics Angiotensin-converting enzyme inhibitors Nonsteroidal anti-inflammatory drugs No active peptic ulcer disease No chronic diarrhea

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004284

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas

1. Study Identification

Unique Protocol Identification Number

NCT00004284

Brief Title

Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria

Study Type

Interventional

2. Study Status

Record Verification Date

June 2000

Overall Recruitment Status

Completed

Study Start Date

April 1995 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas

4. Oversight

5. Study Description

Brief Summary

OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.

Detailed Description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. Patients receive potassium phosphate or potassium citrate tablets twice a day for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercalciuria, Kidney Calculi

Keywords

hypercalciuria, nephrolithiasis, rare disease, renal and genitourinary disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

Double

Allocation

Randomized

Enrollment

300 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

potassium citrate

Intervention Type

Drug

Intervention Name(s)

potassium phosphate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Absorptive hypercalciuria Intestinal hyperabsorption of calcium, i.e.: Exaggerated calciuric response to oral calcium load OR Fractional calcium-47 absorption greater than 0.61 Calciuria greater than 200 mg/day on random and calcium-restricted diet Normal or high fasting urinary calcium Normal serum calcium Normal serum parathyroid hormone No primary hyperparathyroidism At least 1 calcium oxalate stone within the past 3 years No struvite or carbonate apatite stones No noncalcareous stones No numerous stones making precise quantitation difficult No renal tubular acidosis --Prior/Concurrent Therapy-- No concurrent drug therapy for nephrolithiasis --Patient Characteristics-- Creatinine clearance at least 0.7 mL/min per kilogram No hyperkalemia No hyperphosphatemia No urinary tract infection Other: No predisposition to hyperkalemia, including concurrent use of the following drugs: Potassium-sparing diuretics Angiotensin-converting enzyme inhibitors Nonsteroidal anti-inflammatory drugs No active peptic ulcer disease No chronic diarrhea

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles Y. C. Pak

Organizational Affiliation

University of Texas

Official's Role

Study Chair

Hypercalciuria, Kidney Calculi

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial