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Kidney, PolycysticPhase 3HALT PKD ANCT00283686

HALT Progression of Polycystic Kidney Disease Study A

A Phase 3 study testing Lisinopril and Telmisartan in people with Kidney, Polycystic, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 64 years
Conditions the study is for
Kidney, Polycystic
What is being tested?
Lisinopril and Telmisartan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
558 participants
Where
7 sitesUnited States
Study dates
Jan 2006to Jun 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 64 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis of ADPKD.
  • Age 15-49 (Study A); Age 18-64 (Study B).
  • GFR >60 mL/min/1.73 m2 (Study A); GFR 25-60 mL/min/1.73 m2 (Study B).
  • BP ≥130/80 or receiving treatment for hypertension.
  • Informed Consent.

Who cannot join

  • Pregnant/intention to become pregnant in 4-6 yrs.
  • Documented renal vascular disease.
  • Spot urine albumin-to-creatinine ratio of >0.5 (Study A) or ≥1.0 (Study B) and/or findings suggestive of kidney disease other than ADPKD.
  • Diabetes requiring insulin or oral hypoglycemic agents / fasting serum glucose of >126 mg/dl / random non-fasting glucose of >200 mg/dl.
  • Serum potassium >5.5 milliequivalent per liter (mEq/L) for participants currently on ACE-I or ARB; >5.0 mEq/L for participants not currently on ACE-I or ARB.
  • History of angioneurotic edema or other absolute contraindication for ACE-I or ARB. Intolerable cough associated with ACE-I is defined as a cough developing within six months of initiation of ACE-I in the absence of other causes and resolving upon discontinuation of the ACE-I.
Show all 17Show fewer
  • Indication (other than hypertension) for β-blocker or calcium channel blocker therapy (e.g. angina, past myocardial infarction, arrhythmia), unless approved by the site principal investigator. (PI may choose to accept an individual who is on only a small dose of one of these agents and would otherwise be eligible.)
  • Systemic illness necessitating nonsteroidal antiinflammatory drugs (NSAIDs), immunosuppressant or immunomodulatory medications.
  • Systemic illness with renal involvement.
  • Hospitalized for acute illness in past 2 months.
  • Life expectancy <2 years.
  • History of non-compliance.
  • Unclipped cerebral aneurysm >7mm diameter.
  • Creatine supplements within 3 months of screening visit.
  • Congenital absence of a kidney (also total nephrectomy for Study B).
  • Known allergy to sorbitol or sodium polystyrene sulfonate.
  • Exclusions specific to magnetic resonance imaging (Study A).

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • University of Colorado Health Sciences Center

    Aurora, Colorado, 800045

  • Tufts University-New England Medical Center

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 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.

Read the 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 mL/min/1.73m2)and high-normal blood pressure or hypertension (>130/80 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 mL/min/1.73 m2), multi-level blockade of the RAAS using ACE-I/ARB 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.

Being tested
Lisinopril, Telmisartan, Placebo, Standard Blood Pressure Control, Low Blood Pressure Control
Keywords
polycystic kidney disease, polycystic, kidney, disease, adpkd, halt, pkd, blood pressure, bp, hypertension, renal, renin-angiotensin-aldosterone-system, RAAS
Medical subject headings
Polycystic Kidney Diseases, Disease, Polycystic Kidney, Autosomal Dominant, Familial paroxysmal dystonia, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LisinoprilDrug

    Also called ACE-I, ACE, Ace-Inhibitor

    Lisinopril titrated to 5mg, 10mg, 20mg, 40mg

  • TelmisartanDrug

    Also called ARB

    Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants

  • PlaceboDrug

    Telmisartan/Placebo titrated to 40mg and 80mg, as tolerated by participants

  • Standard Blood Pressure ControlOther

    Also called blood pressure control

    Achieve standard blood pressure control of 120-130/70-80 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator

  • Low Blood Pressure ControlOther

    Also called blood pressure control

    Achieve low blood pressure control of 95-110/60-75 mm Hg using step dosing specified in protocol of lisinopril, study drug, hydrochlorothiazide, metoprolol, or non-dihydropyridine and dihydropyridine calcium channel blockers (diltiazem), clonidine, minoxidil, hydralazine at the discretion of the investigator

Study groups in NCT00283686
Study groupRoleWhat they receive
Study A, Arm 1Active comparatorLisinopril + Telmisartan (ACE-I + ARB) and standard blood pressure control of 120-130/70-80 mm Hg
Receives: Drug: Lisinopril; Drug: Telmisartan; Other: Standard Blood Pressure Control
Study A, Arm 2Active comparatorLisinopril + Telmisartan (ACE-I + ARB) and low blood pressure control of 95-110/60-75 mm Hg
Receives: Drug: Lisinopril; Drug: Telmisartan; Other: Low Blood Pressure Control
Study A, Arm 3Placebo comparatorLisinopril + Placebo (ACE-I + Placebo) and standard blood pressure control of 120-130/70-80 mm Hg
Receives: Drug: Lisinopril; Drug: Placebo; Other: Standard Blood Pressure Control
Study A, Arm 4Placebo comparatorLisinopril + Placebo (ACE-I + Placebo) and low blood pressure control of 95-110/60-75 mm Hg
Receives: Drug: Lisinopril; Drug: Placebo; Other: Low Blood Pressure Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study A: Percent Annual Change in Total Kidney Volume

    Annual percentage change in total kidney volume as assessed by abdominal magnetic resonance imaging (MRI) at baseline, 2 years, 4 years, and 5 years follow-up.

    Measured: Baseline and 2-, 4- and 5-year follow-up

Secondary outcomes (8)

  1. Kidney Function (eGFR)

    The estimated GFR was calculated by means of the Chronic Kidney Disease Epidemiology Collaboration equation with the use of central serum creatinine measurements.

    Measured: Up to 96 months (6 month assessments)

  2. Albuminuria

    Urine albumin excretion, centrally processed from 24 hour urine collection

    Measured: Up to 96 months (assessed annually)

  3. Aldosterone

    Urinary aldosterone excretion, centrally processed, 24 hour urine collection

    Measured: Up to 96 months (assessed annually)

  4. Left Ventricular Mass Index

    Left ventricular mass index (g/m^2) measured by MRI, centrally reviewed and measured

    Measured: 0, 24 months, 48 months, 60 months

  5. Renal Blood Flow

    renal blood flow (mL/min/1.73 m^2) from MRI, centrally reviewed and measured. This outcome was more difficult to measure resulting in more missing data than other MRI outcomes such as total kidney volume (TKV) and left ventricular mass index (LVMI).

    Measured: 0, 24 months, 48 months, 60 months

  6. All-Cause Hospitalizations

    Measured: Up to 96 months

  7. Quality of Life Physical Component Summary

    Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)

    Measured: baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)

  8. Quality of Life Mental Component Summary

    Short Form-36 Quality of LIfe Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome)

    Measured: baseline, 12, 24, 36, 48, 60, 72, 84, and 96 months (assessed annually)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
558 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00283686
Sponsor's protocol ID
HALT PKD A
Other IDs
U01DK062401, U01DK082230
Acronym
HALT PKD A
Status last verified
Apr 2020
First submitted
26 Jan 2006
Last updated
21 Apr 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data are available at the NIDDK Central Repository, https://repository.niddk.nih.gov/studies/halt-pkd/?query=halt%20pkd

Publications

  • Heerspink HJL, Collier WH, Chaudhari J, Miao S, Tighiouart H, Appel GB, Caravaca-Fontan F, Floege J, Hannedouche T, Imai E, Jafar TH, Lewis JB, Li PKT, Locatelli F, Maes BD, Neuen BL, Perkovic V, Perrone RD, Remuzzi G, Schena FP, Wanner C, Greene T, Inker LA. A meta-analysis of albuminuria as a surrogate endpoint for kidney failure. Nat Med. 2026 Jan;32(1):281-287. doi: 10.1038/s41591-025-04057-z. Epub 2025 Nov 6.

    PubMed 41198855

  • St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

    PubMed 39356039

  • Heerspink HJL, Inker LA, Tighiouart H, Collier WH, Haaland B, Luo J, Appel GB, Chan TM, Estacio RO, Fervenza F, Floege J, Imai E, Jafar TH, Lewis JB, Kam-Tao Li P, Locatelli F, Maes BD, Perna A, Perrone RD, Praga M, Schena FP, Wanner C, Xie D, Greene T; on behalf of CKD-EPI CT. Change in Albuminuria and GFR Slope as Joint Surrogate End Points for Kidney Failure: Implications for Phase 2 Clinical Trials in CKD. J Am Soc Nephrol. 2023 Jun 1;34(6):955-968. doi: 10.1681/ASN.0000000000000117. Epub 2023 Mar 15.

    PubMed 36918388

  • Kim K, Trott JF, Gao G, Chapman A, Weiss RH. Plasma metabolites and lipids associate with kidney function and kidney volume in hypertensive ADPKD patients early in the disease course. BMC Nephrol. 2019 Feb 25;20(1):66. doi: 10.1186/s12882-019-1249-6.

    PubMed 30803434

  • Schrier RW, Abebe KZ, Perrone RD, Torres VE, Braun WE, Steinman TI, Winklhofer FT, Brosnahan G, Czarnecki PG, Hogan MC, Miskulin DC, Rahbari-Oskoui FF, Grantham JJ, Harris PC, Flessner MF, Bae KT, Moore CG, Chapman AB; HALT-PKD Trial Investigators. Blood pressure in early autosomal dominant polycystic kidney disease. N Engl J Med. 2014 Dec 11;371(24):2255-66. doi: 10.1056/NEJMoa1402685. Epub 2014 Nov 15.

    PubMed 25399733

  • Hogan MC, Abebe K, Torres VE, Chapman AB, Bae KT, Tao C, Sun H, Perrone RD, Steinman TI, Braun W, Winklhofer FT, Miskulin DC, Rahbari-Oskoui F, Brosnahan G, Masoumi A, Karpov IO, Spillane S, Flessner M, Moore CG, Schrier RW. Liver involvement in early autosomal-dominant polycystic kidney disease. Clin Gastroenterol Hepatol. 2015 Jan;13(1):155-64.e6. doi: 10.1016/j.cgh.2014.07.051. Epub 2014 Aug 9.

    PubMed 25111236

  • Torres VE, Chapman AB, Perrone RD, Bae KT, Abebe KZ, Bost JE, Miskulin DC, Steinman TI, Braun WE, Winklhofer FT, Hogan MC, Oskoui FR, Kelleher C, Masoumi A, Glockner J, Halin NJ, Martin DR, Remer E, Patel N, Pedrosa I, Wetzel LH, Thompson PA, Miller JP, Meyers CM, Schrier RW; HALT PKD Study Group. Analysis of baseline parameters in the HALT polycystic kidney disease trials. Kidney Int. 2012 Mar;81(6):577-85. doi: 10.1038/ki.2011.411. Epub 2011 Dec 28.

    PubMed 22205355

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lisinopril and Telmisartan in people with Kidney, Polycystic, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study A: Percent Annual Change in Total Kidney Volume (time frame: Baseline and 2-, 4- and 5-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00283686, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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