Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283686
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2006-01-26
Brief Title:
HALT Progression of Polycystic Kidney Disease Study A
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
HALT Progression of Polycystic Kidney Disease Study A
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HALT PKD A
Brief Summary:
The efficacy of interruption of the renin-angiotensin-aldosterone system RAAS on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease ADPKD will be assessed in two multicenter randomized clinical trials targeting different levels of kidney function 1 early disease defined by GFR 60 mLmin173 m2 Study A and 2 moderately advanced disease defined by GFR 25-60 mLmin173 m2 Study B NCT01885559 Participants will be recruited and enrolled either to Study A or B over the first three years Participants enrolled in Study A will be followed for at least 5 years while those enrolled in Study B will be followed for five-to-eight years with the average length of follow-up being six and a half years The two concurrent randomized clinical trials differ by eligibility criteria interventions and outcomes to be studied
Detailed Description:
Specific Aims of Study A
To study the efficacy of angiotensin-converting-enzyme inhibitor ACE-I and angiotensin-receptor blockade ARB combination therapy as compared to ACE-I monotherapy and usual vs low blood pressure targets on the percent change in kidney volume in participants with preserved renal function GFR 60 mLmin173m2and high-normal blood pressure or hypertension 13080 mm Hg
Hypotheses to be tested in Study A
In ADPKD individuals with hypertension or high-normal blood pressure and relatively preserved renal function GFR 60 mLmin173 m2 multi-level blockade of the RAAS using ACE-IARB combination therapy will delay progression of cystic disease as compared to ACE-I monotherapy and a low blood pressure goal will delay progression as compared with standard control
To study the efficacy of angiotensin-converting-enzyme inhibitor ACE-I and angiotensin-receptor blockade ARB combination therapy as compared to ACE-I monotherapy and usual vs low blood pressure targets on the percent change in kidney volume in participants with preserved renal function GFR 60 mLmin173m2and high-normal blood pressure or hypertension 13080 mm Hg
Hypotheses to be tested in Study A
In ADPKD individuals with hypertension or high-normal blood pressure and relatively preserved renal function GFR 60 mLmin173 m2 multi-level blockade of the RAAS using ACE-IARB combination therapy will delay progression of cystic disease as compared to ACE-I monotherapy and a low blood pressure goal will delay progression as compared with standard control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK082230 | NIH | None | httpsreporternihgovquickSearchU01DK082230 |
| U01DK062401 | NIH | None | None |