Updated: 4/21/2016

Active Studies – No Longer Recruiting

Kansas

Massachusetts

Nationwide

International

Not Listed

Open-Label Tolvaptan Study in Subjects With ADPKD (TEMPO 4/4)

Enrolling by invitation only. The purpose is to demonstrate whether Tolvaptan modifies ADPKD progression as measured by changes from baseline in total kidney volume (TKV) and renal function.

Intervention
Drug: Tolvaptan

Age Group:
Not listed

Location(s):
Not listed

Participation Information:

Inclusion Criteria:

  • Subjects who have successfully completed a Phase 1, 2, or 3 tolvaptan ADPKD or renal impairment trial, with a confirmed diagnosis of ADPKD

Exclusion Criteria:

  • Subjects unable to provide written informed consent
  • Subjects (men or women) who will not adhere to the reproductive precautions as outlined in the Informed Consent Form
  • Subjects (women only) with a positive urine pregnancy test
  • Subjects who are pregnant or breast-feeding
  • Subjects unable to take oral medications
  • Subjects who have allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate or mirtazapine)
  • Subjects who have disorders in thirst recognition or an inability to access fluids
  • Subjects with critical electrolyte imbalances, as determined by the investigator
  • Subjects with or at risk of significant hypovolemia, as determined by investigator
  • Subjects with anemia, as determined by investigator
  • Subjects with a history of substance abuse (within the last 3 years)
  • Subjects taking other experimental (ie, non-marketed) therapies or current participation in another clinical drug or device trial; current participation in the off-drug follow-up period of another ADPKD trial with tolvaptan is permitted

Efficacy Analysis Exclusion Criteria:

  • Subjects unable to complete MRI assessments(eg, subjects with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia)
  • Subjects who have taken a vasopressin antagonist (outside of previous participation in a tolvaptan trial)
  • Subjects unable to comply with anti-hypertensive or other important medical therapy
  • Subjects with advanced diabetes
  • Subjects taking medications or having an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting PKD cysts)

Contact Information:
Enrolling by invitation only

Website:
http://www.clinicaltrials.gov/ct/show/NCT01214421

Somatostatin in Patients with ADPKD and Moderate to Severe Renal Insufficiency (ALADIN 2)

To assess the efficacy of one year treatment with long-acting somatostatin analogue (Octreotide LAR) compared to placebo in slowing kidney and liver growth rate in patients with ADPKD and moderate/severe renal insufficiency.

Intervention
Octerotide-LAR

Age Group:
18 to 75 years

Location(s):
Italy

Participation Information:

Inclusion Criteria:

  • Clinical and ultrasound diagnosis of ADPKD
  • Estimated GFR between 15 and 40 ml/min/1.73m2 (by the MDRD 4 variable equation)
  • Written informed consent

Exclusion Criteria:

  • 24-h Urinary protein excretion rate >3g (suggestive of a concomitant glomerular disease that could benefit of specific therapy)
  • Symptomatic urinary tract lithiasis or obstruction
  • Uncontrolled diabetes mellitus (HbA1c >8%) or hypertension (systolic/diastolic BP >180/110 mmHg)
  • Current urinary tract infection
  • Symptomatic biliary tract lithiasis
  • Active cancer
  • Psychiatric disorders or any condition that might prevent full comprehension of the purposes and risks of the study
  • Pregnancy, lactation or child bearing potential and ineffective contraception (estrogen therapy in post menopausal women should not be stopped)

Contact Information:
Norberto Perico, Mario Negri Institute for Pharmacological Research

Website:
http://clinicaltrials.gov/ct2/show/NCT01377246

A New Diet for Patients with Autosomal Dominant Polycystic Kidney Disease

Recent evidence has shown that kidney volume predicts the likelihood of developing renal insufficiency over a finite length of time in ADPKD, suggesting a linkage between the growth of cysts and the harm they do to kidney function. Recent studies indicate that the rate of kidney volume increase is hastened by excess dietary protein, salt, and potential net acid precursors, and slowed by increased water intake sufficient to lower plasma vasopressin levels.

Diets are commonly prescribed to treat ADPKD and other renal patients with disease near the end-stage, but there is currently no specific diet prescription that takes potentially harmful dietary elements into account for ADPKD patients in the earliest stages of the disease. This study will examine a novel diet for ADPKD created by the researcher termed the ADPKD diet.

Intervention
ADPKD Diet

Age Group:
18 to 65 years

Location(s):
University of Kansas Medical Center – Kansas City, Kan.

Participation Information:

Inclusion Criteria:

  • Have not been prescribed dietary restrictions or enhancements
  • Blood pressure <135/85 mmHg with or without specific treatment
  • Willingness to participate for at least one month
  • Diet history consistent with the excretion of >30 mEq NAE / day based on usual dietary intake

Exclusion Criteria:

  • Other active diseases requiring pharmacologic agents
  • Unstable weight (+/- 2 kg) for 3 months prior to enrollment
  • Food allergies
  • Pregnancy or lactating
  • Confounding medications, i.e. bicarbonate, citrate
  • Individuals who do not consume meat for personal, religious, or health reasons

Contact Information:
Principal Investigator: Franz Winklhofer, M.D.

Website:
http://clinicaltrials.gov/ct2/show/NCT01810614

A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients with ADPKD (Extension of Trial 156-04-251)

To continue ADPKD patients enrolled in Trial 156-04-251 on oral Tolvaptan twice daily.

Intervention
Drug: tolvaptan

Age Group:
23 to 53 years

Location(s):
Japan, various locations

Participation Information:

Inclusion Criteria:

  • Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed
  • Patients who completed 3-year repeated administration, and who completed the second follow-up visit, or patients whose treatment with the trial drug was interrupted due to pregnancy and who completed the second follow-up visit in Trial 156-04-251
  • Patients in whom any adverse events occurring in Trial 156-04-251 were resolved or stabilized and require no further follow-up

Exclusion Criteria:

  • Patients with eGFR of less than 15 mL/min/1.73 m2
  • Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
  • Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan
  • Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study

Contact Information:
Not listed

Website:
http://clinicaltrials.gov/ct2/show/NCT01280721

Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease

The purpose of this study is to learn if dietary habits can affect vasopressin secretion in patients with autosomal dominant polycystic kidney disease. Vasopressin increases the growth of kidney cysts and accelerates disease progression. Understanding how to control secretion of this hormone based on dietary habits may help to develop treatments to control this disease. The study will include about 60 patients from Tufts Medical Center, and will last for 2 weeks. Blood and urine tests will be done 3 times during the study period. Subjects will be randomly assigned (by chance like flipping a coin) to 1 of 2 study groups. Group 1 will be given instructions to adjust their diet. This will include adjusting the amount of water, protein, and salt intake. Group 2 will have no adjustment of diet or water. The project has tremendous public health relevance, given the large number of people affected by autosomal dominant polycystic kidney disease, and the substantial impact of the disease on morbidity, mortality, hospitalizations, dialysis or transplant, and societal costs of caring for those patients.

Intervention:
Behavioral: Diet and Water Adjustment

Study Phase:
Phase 2 and 3

Age Group:
18 to 60 years

Location(s):
Tufts Medical Center, Boston, Mass.

Participant Information:

  • Must be able to travel to Tufts Medical Center in Boston

Inclusion Criteria

  • Diagnosed with ADPKD
  • Estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73m2 or above

Exclusion Criteria

  • Chronic use of medications known to affect AVP secretion (SSRIs, Opioids, TCAs, Tolvaptan)
  • History of diseases influencing renal concentration capacity (diabetes insipidus, adrenal or thyroid deficiencies, use of lithium, kidney disease other than ADPKD)
  • Baseline hyponatremia (NA below 135 mEq/l)
  • Inability to comply with dietary or fluid requirements
  • Pregnant

Contact Information:
Ron Perrone, M.D., Principal Investigator

Osama Amro, M.D. Sub-Investigator
617.636.8424
oamro@tuftsmedicalcenter.org

Website:
http://clinicaltrials.gov/ct2/show/NCT02225860

Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide (Vitamin B3) in Polycystic Kidney Disease (NIAC-PKD1)

Niacinamide is a form of vitamin B3. Vitamin B3 is found in many foods including yeast, meat, fish, milk, eggs, green vegetables, beans, and cereal grains. Recent studies in mice have shown that niacinamide, at high doses, may slow kidney cyst growth from polycystic kidney disease (PKD). By doing this study, the researchers will determine if a larger, long-term study to test whether niacinamide slows progression of PKD is justified.

Intervention:
Dietary supplement: Niacinamide

Age Group:
18 to 50 years

Location(s):
University of Kansas Medical Center, Kansas City, Kan.

Participant Information:
This study involves 4 visits to the University of Kansas Medical Center during the year. For patients traveling from outside the Kansas City area, a travel allowance of $100 per visit is available, plus up to $100 per hotel stay if needed.

Patients also receive two MRI scans during the study.

Contact Information:
Cathy Creed, RN, BSN
913.588.0053
CCREED@kumc.edu

Website:
http://clinicaltrials.gov/ct2/show/NCT02140814

Study of Lanreotide to Treat Polycystic Kidney Disease (DIPAK1)

The purpose of this study is to investigate whether the somatostatin analogue Lanreotide slows progression of polycystic kidney and liver disease in ADPKD patients.

Intervention:
Drug: Lanreotide

Age Group:
18 to 60 years

Location(s):
Netherlands – see website for more information

Participant Information:

  • Drug therapy, Lanreotide, will be administered via subcutaneous injection

Inclusion Criteria

  • Diagnosis of ADPKD, based upon the modified Ravine criteria; age between 18 and 60 years
  • eGFR (MDRD) between 30 and 60 ml/min/1.73 m2
  • Providing informed consent

Exclusion Criteria

  • Patients who present a safety risk, as the opinion of the investigator
  • Patients who are unlikely to comply with the trial's procedures
  • Patients taking medications or having concomitant illnesses likely to confound endpoint assessments (ex. NSAIDs, cyclosporine, lithium immunosuppressant)
  • Patients having concomitant illnesses likely to confound endpoints (ex. diabetes, proteinuria)
  • Patients who underwent surgical or drainage interventions for cystic kidney disease the year before study-entry or are likely candidates for these procedures within 2 years of start of the study.
  • Patients taking other experimental (i.e. not approved by FDA/EMA or indication of ADPKD) therapies.
  • Patients having used Lanreotide (or another somatostatin analogue) in the 3 months before study start.
  • Patients with known intolerance for Lanreotide (or another somatostatin analogue).
  • Unwillingness to comply with reproductive precautions. Women who are capable of becoming pregnant must be willing to comply with approved birth control from two-weeks prior to, and for 60 days after taking investigational product.
  • Women who are pregnant or breastfeeding.
  • Patients who suffer from cardiac arrhythmias
  • Patients who have ever suffered from symptomatic gallstones and did not undergo cholecystectomy.
  • Patients who have a medical history of pancreatitis.
  • Patients who have a medical history of infected liver cysts.

Contact Information:
Esther Meijer, M.D., Ph.D.
esther.meijer@umcg.nl

Ron Gansevoort, M.D., Ph.D.
r.t.gansevoort@umcg.nl

Website:
http://www.clinicaltrials.gov/ct2/show/NCT01616927

Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to ADPKD (REPRISE)

The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD).

Intervention:

  • Drug: Tolvaptan (OPC-41061)
  • Drug: Placebo

Study Phase:
Phase 3b

Age Group:
18 to 65 years

Location(s):
Various locations throughout the United States – see website for more information.

Participant Information:

  • Must visit the study clinic up to 25 times
  • Depending on your circumstances, you may be offered an opportunity to have certain study visits performed at your home or another location more convenient than the study clinic, if this option is available in your region.
  • Take the investigational medication twice a day as directed by the study doctor.
  • Have blood and urine tests.
  • Drink enough fluids (a minimum of 8 to 12 glasses during the day).

Inclusion Criteria

  • eGFR between 25-65 mL/min/1.73m2 (If age 18-55) or eGFR between 25-44 mL/min/1.73m2 (if age 56-66)
  • Tolvaptan naïve
  • Diagnosed with ADPKD by modified pei-Ravine criteria 1.3 cysts per kidney by sonography or 5 cysts by CT or MRI with family history of ADPKD or 2.10 cysts per kidney by any radiologic method and exclusions of other cystic kidney diseases if without family history

Exclusion Criteria

  • Women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP
  • Women who are breast-feeding and/or who have a positive pregnancy test prior to receiving IMP
  • Need for chronic diuretic use
  • Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease
  • Advanced diabetes, evidence of additional significant renal disease, renal cancer, single kidney, recent renal surgery or acute kidney injury
  • Contraindications to required trial assessments
  • Medical history or medical findings inconsistent with safety or compliance with trial assessments

Contact Information:
reprisesudy@40mmgct.com  – see website for contact information

Website:
http://www.pkdstudy.com or http://www.clinicaltrials.gov/ct2/show/NCT02160145

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©2018, PKD Foundation ·The PKD Foundation is a 501 (c)(3), 509 (a)(1) public charity.

©2018, PKD Foundation ·The PKD Foundation is a 501 (c)(3), 509 (a)(1) public charity.