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Clinical Trials/CTRI/2017/07/009179
CTRI/2017/07/009179
Completed
Phase 2

A Randomized, Double Blind, Placebo Controlled, Phase 2 Study to Assess the Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of LNP1892 (Monotherapy) in Chronic Kidney Disease (CKD) Patients with Secondary Hyperparathyroidism (SHPT), On Dialysis and Not on Dialysis

upin Limited0 sites189 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
upin Limited
Enrollment
189
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
April 24, 2019
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
upin Limited

Eligibility Criteria

Inclusion Criteria

  • •1\) Ambulatory patients of either gender with \>\=18 years of age with diagnosis of SHPT associated with CKD, with Estimated Glomerular Filtration Rate (eGFR) \<30 and willing to provide informed consent
  • •2\) CKD (Stage 4 \& 5\) patients with SHPT, on Hemodialysis (or) Not on Hemodialysis and fulfilling additional criteria given below.
  • •CKD Patients not on Hemodialysis \-
  • •1\. Patients with mean of 2 intact parathyroid hormone (iPTH) values obtained during the screening period \>\=110 pg/mL/ 12\.1 pmol/L (CKD stage 4\) or \>\=300 pg/mL/ 33 pmol/L (CKD stage 5\)
  • •CKD Patients on Hemodialysis
  • •1\. Patients must be receiving maintenance hemodialysis 3 times weekly OR a minimum of 10 hemodialysis/ month for at least 3 months
  • •2\. Patients with mean of 2 intact parathyroid hormone (iPTH) values obtained during the screening period at least 300 pg/mL (33 pmol/L) and not greater than 1200 pg/mL (132 pmol/L)
  • •3\. Patients who have not used cinacalcet or are justified to shift from current cinacalcet use for any of the following reasons \-
  • •1 \> Patients not tolerating cinacalcet:
  • •a. Nausea/ Vomiting

Exclusion Criteria

  • •1\. History of Primary hyperparathyroidism
  • •2\. Subject has known sensitivity to any of the products or components to be administered during dosing.
  • •3\. Anticipated or scheduled kidney transplant during the study period.
  • •4\. Parathyroidectomy within 3 months prior to screening or parathyroid surgery is planned or anticipated during the study
  • •5\. Change in dialysate calcium concentration in the 30 days prior to Day 1
  • •6\. Patients on peritoneal dialysis
  • •7\. History of symptomatic ventricular dysrhythmias or torsades de pointes, uncontrolled hypertension, symptoms of angina pectoris at rest or minimal activity, congestive heart failure (New York Heart Association Class III or IV ), history of myocardial infarction, coronary angioplasty, coronary arterial bypass grafting within 6 months prior to screening
  • •8\. Treatment of a seizure disorder or history of seizure in the last 12 months prior to screening.
  • •9\. Participation in another investigational trial in the past 1 month prior to screening.
  • •10\. Women who are pregnant, lactating, or planning pregnancy while enrolled in the study and at least 3 month after last dose of the IP

Outcomes

Primary Outcomes

Not specified

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